CN102612703A - Method and apparatus for verification of medication administration adherence - Google Patents

Method and apparatus for verification of medication administration adherence Download PDF

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CN102612703A
CN102612703A CN2010800521051A CN201080052105A CN102612703A CN 102612703 A CN102612703 A CN 102612703A CN 2010800521051 A CN2010800521051 A CN 2010800521051A CN 201080052105 A CN201080052105 A CN 201080052105A CN 102612703 A CN102612703 A CN 102612703A
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medicine
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prescription
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CN102612703B (en
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亚当·哈尼娜
戈登·克斯勒
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AI Cure Technologies LLC
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AI Cure Technologies LLC
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Priority claimed from US12/620,686 external-priority patent/US20110119073A1/en
Priority claimed from US12/646,383 external-priority patent/US20110153360A1/en
Priority claimed from US12/646,603 external-priority patent/US8666781B2/en
Priority claimed from US12/728,721 external-priority patent/US9183601B2/en
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    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients

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Abstract

A system and method of confirming administration of medication is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.

Description

The confirmation method of drug administration compliance and device thereof
Technical field
The present invention is broadly directed to the patient's submissiveness in clinical medicine test, and relates in clinical testing the monitoring to patient more specifically, instruction and intervening, thus improve the submissiveness of required medicine rules according to these tests.The present invention also is broadly directed to the clinical medicine test or other drug is taken the patient's submissiveness in the rules situation; And relate to the device that is used to gather, analyze and transmit data more specifically; These data relate at clinical testing or other drug takes in the rules situation monitoring to patient; Instruction and intervention, thus the compliance of ethical goods rules improved according to it.
Background technology
Dr Lars Osterberg, M.D. and Dr, Terence Blaschke on New England Journal of Medicine, Drug compliance( AdherenceTo Medication, N Engl J Med 2005; 353:487-97) reported that the compliance of required medicine rules is troubling in 2005, although the author further points out the compliance mean value " height " of clinical testing, this numerical value still only comprises 43-78%.The more important thing is that the author exists Compliance (Adherence), point out " ability that the physician discerns non-compliance is lower, improves the intervention result (bad mixed results) both worried and glad of compliance " for 487 pages.This author exists Compliance (Adherence), " the low compliance of pharmaceutical admixtures is very general, thereby causes a large amount of deteriorations of disease, death and the medical treatment & health expense that increases in 494 pages of deductions.”。 Trend report series, 2008, the raising of patient dependence: the new side of success Method (The Trend Repot Series, 2008Patient Adherence Update:New Approaches for Success,) in October, 2008, reported similar statistics gloomy.And the present invention is intended to reverse the background of this low compliance and to the potential danger of patient.
Existing a large amount of system can provide about when taking the instruction of medicine and the record when user took medicine to the user.United States Patent(USP) No. 7,359,214 have described a kind of like this system.This equipment provides instruction to the patient who takes medicine.And, considering patient's situation and the other drug that he or she possibly take, this system also is provided for confirming the method that this prescription is whether suitable.Through making up a prescription according to predetermined treatment protocol, this system also is provided for the method for monitor patients to the submissiveness of this scheme.And this system also provides a lot of improvement, is used for the burden of alleviating patient, and this system is applicable to multiple mode, particularly relevant for the mode of clinical testing.
The more important thing is that [0004] this system does not provide mechanism to be used for actual affirmation patient and ingests really or adopt other modes to take at the desired required medicine of clinical medicine test.Though this system is enough for the people who has intelligence fully, those still possibly still not take required medicine to the people who consults the inconvenient people of guide or painstakingly avoid medicine after medicament distribution.Therefore, the participant maybe be forgetful, vision disorder, or other distrust the curative effect of this medicine, thus possibly not write down drug administration.In addition, this system requirements joins divider in advance with various medicines, therefore possibly require managerial personnel to make regular check on, thereby confirm that suitable medicine suitably is added into wherein really.What be sure of is, the user who lacks experience probably adds equipment with the medicine of mistake, perhaps also might be for a certain reason the dosage of mistake be added equipment.In addition; For possible more complicated scheme; Method can not guarantee that the user can follow this rules; And confirm that subsequently the user takes the medicine of all requirements really according to any instruction that provides etc., perhaps take medicine according to one or more instructionss or other suggestion processes.In addition, this system price is expensive, and requires often to safeguard to confirm that each mechanical component are in normal operation.
U.S. Patent application No.11/839; 723; The applying date: 2007-8-16, name is called: the mobile wireless medication management system provides a kind of medication management system that adopts mobile unit and image technology; The pill that makes the user to take shows system, and this system just can discern this medicine then.The keeper can obtain history information, and this history information comprises the various signal of interests through this systematic survey.Image can relate to patient, supplier, medicament reservoir etc.Though this system declares to guarantee the compliance of rules, this system only can provide the desired help by the user.And in fact not specific method can guarantee certain compliance or medicine drug effect compliance relation along with the time.When customizing pharmaceutical admixtures according to customer demand or monitoring individual pharmaceutical admixtures, this point particular importance.
In addition, existing systems fails to keep the tracking examination that is used for medical science official inspection management, and can not further confirm suitable drug administration.Existing systems also is unpractical basically, because this system fails to satisfy a large amount of other requirements of health care of patient, comprises bill; Insurance secretarial work and submission; About healthy living with rationally make the education of medicament, obtain the medicine of replacement easily, and feedback is provided to the medical science service provider; For example, thus prior to providing feedback that the medical science supplier can be prepared for current agreement before the agreement.
People generally recognized be used to guarantee individuality is ingested or the method and system of taking suitable medicine for defence in order to avoid unnecessary disease, dead and other troubles are crucial.It is not very smooth providing instruction and patient being taken care of oneself be proved what carry out.This is because of the main cause of medical risks and is not only the incorrect of medicine and ingests.And it also is the part of this problem that the patient that whole shortage is enough instructs.Further, can't the suitable prescribed regimen of affirmation be provided to the user also is the first cause that in these drug uses, possibly cause a large amount of other problemses.
Specific appointment rules are lacked the final approval that compliance may influence the particular medication treatment; Make that valuable medicine can not be towards the public; And it is out of court to cause on market, obtaining the medicine that drugmaker's multi-billion dollar supports, these situation more are a problem in clinical testing in the works.In addition, in clinical medicine test, possibly cause unfavorable data aggregation and evaluation, thereby thereby cause failing in test and the death recited above that causes thinks that this medicine has potential fatal spinoff not complying with of rules of prescription.In clinical medicine test, also possibly relate to patient's performance and deviation occur with the performance that test design person is recommended to the unfavorable compliance of prescription rules; Except unsuitable drug administration; This deviation also comprises the incorrect timing of taking; The for example diet sincere advice of this field is smoked, perhaps or even to the suggestion of participant about further investigation and follow-up investigation.Especially, in clinical testing, patient's this any unfavorable medicine submissiveness all possibly cause unsuitable result or consequence.
Impaired or incomplete clinical testing data; In follow-up medicine scheme, all be invalid; The intrinsic characteristic of clinical testing self makes complicacy consuming time further complicated more with expensive approval procedure, and this process possibly need the time of cost 8-12 and the expense that surpasses 900,000,000 dollars.Even after initial clinical trial testing is accomplished, there is not system can be used for further monitoring usually, the patient after perhaps monitoring is taken medicine in the use in IV stage yet.The possibility of considering the clinical trial testing failure is to guarantee drug safety, and this additional test maybe be very important.Intrinsic clinical testing method has a large amount of common mistakes, and these mistakes to be existing clinical testing rules all can't overcome at present.
Traditionally, the participant is take part in person explanation and tracking clinical testing.Data acquisition all is subject to patient's interrogation usually, but not carry out every day.For example the classic method calculated of patient consulting and pill has been proved to be and has been not suitable for measuring compliance, and can not provide about quantimeter the time and the information of medicine holiday (drug holidays, continuous three days or more days disobedience medicament).
The submissiveness technology can improve the statistics effect of clinical testing.Through the use of this technology, clinical testing can accurately link together with drug use history.The data of gathering can link together with other resources (for example EDC, the data that patient's diary and doctor are gathered).This technology can be created the multiple possibility of remote access and data acquisition.There is the intelligent packaging technology; Such as computer chip technology that can radio frequency identification (RFID); The cover plate packing of intelligence and microelectromechanical systems lid (MEMS caps; The microprocessor of bottle cap the inside), these technology have following characteristics: a) have invasion property and need health directly to contact with medicine; B) uncertainty of patient's submissiveness---patient just can activate this technology under the situation of medicine of not ingesting; C) cause most of drugmaker and biotechnology company all in clinical testing, not to be come into operation owing to it is expensive; And d) need take a long time enforcement.
People such as Jo Carol report that " although in clinical program and impracticable, the most believable method that is used to study purpose possibly be a kind of method of combination, comprises that pill calculates patient's self-report, and electronic monitoring." (people such as Carol J., the retrovirus drug model, the value of electronic monitoring, AIDS, 17 (12), ppl, 763-767,2003-10).Up to now, these technology only are used to monitor submissiveness individually rather than promote submissiveness.In addition, do not provide a kind of comprehensive system can allow the management of a plurality of patients and patient population yet.And prior art possibly allow to discern low clothes follower, is described below, and system proposed by the invention will help lend some impetus to the submissiveness of medicine and handle some difficult problems that in the clinical testing process, run into.
Another difficult problem is exactly to attempt perfect protection about letter of consent and clinical testing, but all is successfully to avoid potential lawsuit usually.CenterWatch carried out an investigation (Getz, K.A. (2002). Informed consent process:A Survey of subjects assesses strengths and weaknessesApplied clinical Trials, 77 (11), 30-36) be used for estimating the understanding of experimenter to letter of consent, this investigation has further supported patient maybe and not understand the idea of the file that they sign.This investigation has reported that 14% patient is not having just to have signed letter of consent under the situation of reading file.In same investigation, the test that 30% patient report is said them and do not understood them than conventional therapy bear more Duo dangerous and uncomfortable.Patient near 40% does not also know that they can seek the consulting about a difficult problem and worry to the ethics board of directors or the IRB of Ethics Committee.This investigation reports that 41% patient lets research nurse and them check letter of consent together.This investigation also infers 70% participant at the beginning of the signature letter of consent, need maybe and not know what problem of inquiry at last.And this is and the existing information that is provided and closely bound up from the letter of consent institute that these participants receive.From the application,, therefore guarantee that conforming logistics challenge is huge because 77967 tests carrying out about 172 countries are nearly greatly all registered to ClinicalTrials.gov.
For the patient who suffers from mental illness, compliance statistics may be more difficulty, and for example the accurate more method of identifying compliance will be provided according to the technical scheme of a suggestion of the present invention.Investigation (Compliance with Medication regimens for mental and physical disorders according to Cramer and Rosenhek; Psychiatr Serv1998); For the patient who suffers from body illness; The mean value of drug compliance is 76%, and the mean value of suffering from mental illness is 58%, and the mean value of suffering from depression is 65%.Similarly the submissiveness problem also can appear in the treatment of child patient, or the patient that when following the instruction that potential meeting obscures, possibly have difficulties.
Clinical testing according to Bostonian CenterWatch is listed can know that there is the clinical testing above 70000 in the whole world, and annual rate increase with 8-10%, so the logistics challenge of drug compliance and audit clinical testing also increases accordingly to some extent.According to the statistics at this center, the U.S. has 3,600,000 people and has participated in clinical testing in 2003.The self-control of industrialization is necessary; But FDA has only checked 1% clinical testing platform (Department of Health and Human Services between 2000 to 2005; Food and Drug Administration ' s Oversight of Clinical Trails, 2007-9).Along with the demand that medicine increases, can estimate that the ability of these clinical testing platforms of FDA inspection will further descend gradually.In addition; Recruiting the average cost that a patient participates in testing is 6533 dollars; If amount to three times price, so prescreen experimenter and incessantly it to be monitored be quite crucial because thereby non-submissiveness height causes patient death to recruit a new patient then need spend.If unconformable submissiveness appears in the patient of 30% in the clinical testing; Just need the double patient of research to reach identical α and β standard; Consider the above-mentioned fact of having calculated; This number is huge (Pledger G W.Compliance in clinical trials:impact on design, analysis and interpretation.Epilepsy Research 1988 of ten minutes; 2 (suppl): 125-33).
Tufts CSDD Impact Report was illustrated within 3 years; The clinical testing that more sponsor programmes will reach 65% FDA-regulation is placed on the U.S. and carries out-mainly concentrate on Central and Eastern Europe abroad; Latin America, India and Asia-reason are advantage and ready well-trained physicians and a large amount of patients of treatment first economically.In addition, contract clinical service and in total drug development expense, occupied share above 17%.In the near future; Sponsor spends the growth rate of the expense on CRO (the Clinical Research Organization of clinical research mechanism) will surpass the overall growth speed of flower at global drug development; This just reflects and more depends on the ability that contractor provides expansion, the efficient of greater flexibility and Geng Gao.
Along with the clinical testing of bigger quantity is carried out abroad, when existing infrastructure (for example in doctor and nurse's the training) in the time of possibly having defective, this technology can help standardization more and provide better and exchange.
Existing a large amount of system can provide about when taking the instruction of medicine and the record when user took medicine to the user.United States Patent(USP) No. 7,359,214 have described a kind of like this system.This equipment provides instruction to the patient who takes medicine.And, considering patient's situation and the other drug that he or she possibly take, this system also is provided for confirming the method that this prescription is whether suitable.According to predetermined treatment protocol, this system can monitor the distribution of medicine.And this system also provides a lot of improvement, is used for the burden of alleviating patient, and this system is applicable to multiple mode, particularly relevant for the way to manage of clinical testing.
Therefore, it is desirable to provide a kind of method and apparatus that can overcome the defective of prior art.
Summary of the invention
According to the present invention, a kind of system and method that is used for complete control and confirms the compliance of prescription drug rules is provided, no matter be that the health care supplier provides service, still patient's oneself takes care of in residential care.This system and method preferably includes a kind of device, is used to accept user's drug information (profile and the history that comprise medicine); To the user instruction about when taking medicine and take which kind of medicine is provided; To no matter being that the pill or the medicine of packaged form are carried out to picture and go into correct medicine to confirm clothes; According to user's medication history confirm new drug will be not can with obey into medicine (comprising the OTC that patient takes) clash; Packing or the pill that scans one group of medicine be with through visual, and the user informed in oral or other suggestive language, and which kind of is correct medicine; Go into medicine to user's information of offering help to help the suitable clothes of user; Utilize static photo, imaging application or other actions or Gesture Recognition are carried out to picture, help the user to confirm that medicine gone into suitable clothes by certain; Any suitable extra or special instruction is provided; Go the possible spinoff of noticing that any kimonos medicament is relevant through image; Compliance to the prescription rules is carried out cumulative statistics; Ancillary drug is resequenced by demand, and when the user can not correctly follow the prescription rules, notifies the medical expert.
No matter unintentionally or have a mind to from start to finish, native system and method help the rules of following that the user can be correct, notify any difference of keeper and scheme through the user,, thereby early stage intervention is provided.The present invention is the affirmation system of only drug compliance; This system can confirm whether the user follows rules really, and to the user extra help is provided, from instruction; Video instructions etc.; Arrive gradually through phone, mail video conference etc. and medication management person's contact can be benefited from these help if confirm the user.The user is left drug prescription and with suitable medical information input system after; Pharmacists or other medical personnel can allow system to medicine imaging or typing drug information in many ways, thereby corresponding to one or more preferred rules of taking this medicine.According to specifically or the medicine of replacement subsequently, can to the pharmacists image further is provided and with this image as the visual affirmation of adding to guarantee suitable drug administration.This medical personnel can be selected desirable rules then, thereby avoids the point of easy error and to user's false command.In addition, this medicine image can show patient to watch when patient takes medicine, thereby guarantees to take correct medicine.
In addition according to the present invention, the emergency answering personnel, hospital or other medical science ISP etc. all can visit these drug informations.Can expect that these information can be through getting into patient's mobile phone, other mobile devices, or the predetermined program of house system and obtaining.Network address or similar website predetermined can provide further visit.
According to the present invention, the system and method that provides allows prescription drug rules or the employed in the works machine of clinical testing or device are carried out complete control and affirmation, no matter is that the health care supplier provides service, and still patient's oneself takes care of in residential care.
The present invention is used to complete audit and the experimenter in the clinical testing market means of tracking to the medicine submissiveness.The invention provides unique medication management system, this system can confirm whether the user follows rules really, and to the user extra help is provided; From instruction; The contact with medication management person is arrived in beginnings such as video instructions gradually, needs this help if confirm the user.According to the user's in the clinical testing drug prescription, this test design person can select required rules for the user, therefore, not only can test certain drugs, can also easily detect the compliance for given specific a series of instructions.
In recent years; U.S. sanitary and community service department; The chief inspector examines directors that the publication that office (Office of the Inspector General, " OIG ") announces makes (directly or indirectly) handle the health care companies of federal health care affairs and knows clearly that these Fiduciary duties comprise that the responsibility of the board of directors keeps an effectively submissiveness project of cooperation to guarantee health care companies.Increase because the chief inspector examines the submissiveness responsibility of office (OIG), so the submissiveness first executive officer of drugmaker must possess the most comprehensively knowledge, thereby guarantee that their company meets the regulation of any requirement.Failure possibly cause personal liability.Therefore, the ability of keeping audit trail in the works in clinical testing helps to satisfy these requirements.
The novel combination of text, figure, magazine and the video submissiveness problem in the clinical testing that makes obtains overall settlement.System according to the invention provides a large amount of schemes.At first, this system helps to confirm that patient is signing letter of consent.How this system and method can just take medicine to user or healthcare provider, side effects of pharmaceutical drugs and the benefit that has been found that be what and image and video instructions progressively is provided.These characteristics have been avoided the misunderstanding that caused by recipe specifies, the method that can also allow in the world to be adopted, thus overcome possible problems such as aphasis.
When should take medicine thereby a kind of certain drugs scheme can be made into medicine calendar warning user, and the video instructions clearly of taking medicine is provided.This prompting makes the experimenter's in the clinical testing the situation of forgeing minimize, and helps to relate to the for example logistics challenge (logistical challenges) of the complicated pharmaceutical admixtures of double-blind trial (double blind) research and so on.In addition, this medicine calendar and submissiveness result are that the clinical testing organizer obtains easily.
In case warning is sent, patient can confirm that they should prepare to take medicine, and system and method for the present invention is discerned type and the quantity that writes down medicine through image.The experimenter shows that to imaging device whether medicine can the authentication medicine be correct dosage and provides and take instruction.Also comprise for the spendable additive method of the identification of medicine bottle: the RFID label, scanning bar code, text identification, perhaps other the graphic user interface that passes through is discerned, and preferably coordinates mutually with image identification.In case the type of medicine and quantity are through authentication; System and method of the present invention will write down or visually analyze patient to he or she has taken medicine really; Use above-mentioned any one recognition methods; Further comprise face recognition, mark is confirmed, or any other is used to confirm the method for individual character.Be used for the real time record of audit trail and further analyze being created.On equipment, use simple survey can gather additional information, thereby help to give prominence to the problem when taking medicine, for example swallow the tablet or the difficulty of unpacking, perhaps the bad reaction of patient's experience.No matter patient misses and reminds or what the reason of medicine prompting is, system and method for the present invention all can be notified the clinical testing tissue.The data of each colony all can be by real-time collection and online in a concentrated manner, provides real-time data result and mark problem or result early.
Along with the beginning of clinical testing, what whether clinical testing designed rationally will become very obvious very soon, and system and method for the present invention will be given prominence to difficult point in the clinical testing or the property disobeyed.Usually inconvenience or restrictive preventive measure can hinder pharmaceutical admixtures to be followed accurately, and this feedback can be very useful.System of the present invention makes error or wrong data submit to minimize through clinical affairs and drug use are linked.The also traceable behavior of carrying out of this system when problem is given prominence to.This then audit trail will be stored.At last, fail to follow this prescribed regimen if patient is determined, this patient can be identified and from clinical testing colony, be got rid of, perhaps be labeled at least, thereby from medicine whether safety with effectively detect get rid of an interference factor.
This system and method preferably includes a kind of device, and this device is used to accept user's drug information (profile and the history that comprise medicine); To the user instruction of when taking medicine and taking which kind of medicine about according to the prescribed regimen in the clinical testing is provided; To no matter being that the pill or the medicine of packaged form are carried out to picture and go into correct medicine to confirm clothes; According to user's medication history confirm according to the new recipe medicine of clinical testing not can with obey into another kind of medicine (comprising the OTC that patient possibly take) clash; Packing or the pill that scans one group of medicine be with through visual, and the user informed in oral or other suggestive language, and which kind of is correct medicine; Go into medicine to user's information of offering help to help the suitable clothes of user; Use static photo, video program or other actions or Gesture Recognition are carried out to picture, confirm that to help the user medicine gone into suitable clothes by certain; Any suitable extra or special instruction is provided, thereby makes the user can follow the instruction of clinical testing; Use image to go the possible spinoff of notifying any kimonos medicament relevant; Prescription rules compliance is carried out cumulative statistics; Ancillary drug is resequenced by demand, and when the user can not correctly follow the prescription rules, notifies the medical expert.If need, patient's face or other recognition features can be stashed, but logging program is stored, and show that perhaps other use, and do not leak out any one concrete patient's identity.
From start to finish, native system and method help the user can correctly follow by the determined rules of clinical testing plan, and no matter unintentionally or have a mind to any difference of notifying the user to notify keeper and these rules, thereby provide early stage intervention.The present invention is the affirmation system of only drug compliance; This system can confirm whether the user follows these rules really, and to the user extra help is provided, from instruction; Beginnings such as video instructions; Arrive gradually through phone, mail video conference etc. is intervened medication management person, can from these help, be benefited if confirm the user.Through this improved nursing regulation, some potential clinical testing participants will more likely participate in clinical testing.This system can also discern the individuality of from clinical testing colony, getting rid of, and also possibly discern a series of instructions that can not make the people follow prescribed regimen.
According to the present invention, a kind of device also is provided, this device helps the exhibition information to patient; Gather medication compliance information, be included in that residential care is in the works, hospital's plan; The clinical testing plan; Or other are in the works any, and wherein drug compliance possibly be a problem, and other aspects in the method and system part as above explained of the application.Therefore; According to the present invention, a kind of video capture device is provided, comprise being used to store the video of collection and other patient datas' reservoir; Analyze the data of being gathered; The data of being gathered are sent to remote location, accept information, to preferred patient provides information according to the present invention from remote location.According to a preferred embodiment of the present invention; The device that provides comprises: video capture device; Audio collecting device; The reservoir of the storage data of being gathered is applicable to that operation is used to analyze the processor of the analysis software of institute's image data, is used for institute's image data or other data or analysis result are sent to remote location; And be used for receiving data and the further transmitter that instructs or exchange, and one is used for these data or the further display that shows patient that instructs with remote location from remote location.This device preferably is connected with the management software that is applicable to a large amount of patients of management, thereby overall monitor and data-gathering process are provided.
Therefore can estimate that device according to the present invention is applicable to the clinical testing plan; And more medical services plan, such as the residential care that is provided by the health care assistant, perhaps patient's oneself takes care of; Hospital's plan or other clinical program, or other are of value to the situation of drug administration.The ability that constructed device is gathered patient data and drug administration data in more controlled environment according to the present invention will make that the data that collect are more consistent, guarantee the pressure to the compliance of one or more prescription drug schedule of administration thereby alleviate.
In addition, will be according to the present invention when constructed unit describe becomes a kind of method and system of aforesaid enforcement, this device can be freestanding device, is used for being different from using and implementing of the described system of the application.
Other guide of the present invention and advantage will be through instructions and drawings show more clear.
The present invention includes a plurality of steps; And about the relation between one or more steps of each step; Also comprise a kind of device of combination that embodies the combination of characteristic of the present invention, various elements and be adapted to influence each parts of each step; All the elements are listed below with embodiment, shown in protection scope of the present invention such as the claim.
Description of drawings
In order more intactly to understand the present invention, can be with reference to ensuing instructions and Figure of description, wherein;
Fig. 1 shows the process flow diagram of highest function according to an embodiment of the invention;
Fig. 2 shows the process flow diagram of data input according to an embodiment of the invention and prescription assigning process;
Fig. 3 shows the process flow diagram of medical science compliance scheme according to an embodiment of the invention;
Fig. 4 shows the process flow diagram of highest function according to an embodiment of the invention;
Fig. 5 shows the process flow diagram of data input according to an embodiment of the invention and prescription assigning process;
Fig. 6 shows the process flow diagram of medical science compliance scheme according to an embodiment of the invention;
Fig. 7 exemplarily shows the page that gathers of instrument panel according to an embodiment of the invention;
Fig. 8 exemplarily show Fig. 7 amplification gather the page;
Fig. 9 exemplarily shows the information that indicator provided according to each clinical testing participant according to a preferred embodiment of the present invention;
Figure 10 shows the process flow diagram of highest function according to an embodiment of the invention;
Figure 11 shows the process flow diagram of data input according to an embodiment of the invention and prescription assigning process;
Figure 12 shows the process flow diagram of medical science compliance scheme according to an embodiment of the invention;
Figure 13 exemplarily shows the page that gathers of instrument panel according to an embodiment of the invention;
Figure 14 exemplarily show Figure 13 amplification gather the page;
Figure 15 exemplarily shows the information that indicator provided according to each clinical testing participant according to a preferred embodiment of the present invention;
Figure 16 shows the block scheme of embodiments of the invention;
Figure 17 shows the block scheme of the details of the system relevant with embodiments of the invention;
Figure 18 shows the process flow diagram of method according to an embodiment of the invention;
Figure 19 shows the process flow diagram of method according to an embodiment of the invention.
Embodiment
According to the present invention; A kind of system and method is provided; This system and method improves the compliance of medical science rules and for the keeper provides tangible and concrete mode, affirmation compliance or its deficiency guarantee that in intervening in early days of this scheme patient correctly takes their medicine in this mode.System and method of the present invention is used for prescription to be selected, and the indication patient uses any prescription drug, and authentication doctor or other ISPs are to the patient's of prescription rules compliance.
At first, show whole data stream with reference to figure 1.According to the present invention, existing industry drug information database 110 can be used for obtaining prescription, interacts, and application and other are in a large number about the prescription of suggestion and the available information of OTC.In addition, as will be described below, patient's medical record 115 be used to this industry medical information and medical expert the prescription suggestion combine providing medical scheme, and this scheme is input to system of the present invention 120.In case the entering system, a specific prescribed regimen will form a series of user instructions 125.Such user instruction possibly comprise general directions for use; This explanation relates to a certain drugs; The method of ingesting; To the worry of spinoff, to common material or medicine, or other are drawn in favour of the worry of the drug interaction between patient's the other drug by this system or another health care provider.This series of user instruction can interact according to the present invention in expectation, allows the user to read other information about these instructions or prescription if necessary.These instructions possibly comprise written instructions, audio instructions, perhaps video instructions.In addition, estimate the place, arbitrfary point in the instruction group according to the present invention; For example; When patient inquires the problem of particular type, when perhaps requiring to accept the additional information about the particular aspects of medicine or prescribed regimen, if confirm that this medical expert's intervention is desirable to patient; This system can offer assistance and get in touch with the delegation of health care provider, thereby for patient individual's help of extra necessity is provided.Therefore, this patient can get help and suitably take medicine and various mistakes can not take place.In fact, in more traditional situation, only after possibly accomplishing prescribed regimen and feed back to doctor there and can find that just medicine is taken by error.According to the present invention, can stop the consequence of taking any possible misfortune that medicine brings owing to unsuitable for the early intervention of this situation.Can expect that the health care provider or the individual that are mentioned above according to the present invention have patient's instrument panel, are used to manage one or more patients' prescribed regimen.Such instrument panel allows the medical expert to monitor many patients with mode described below; Permission is carried out statistical study to patient dependence with other patient reactions; Information is coupled together; This information comprises the operation program to one or more patient records, and roughly allows the medical expert from unique easily access point their all patients to be monitored and manage medicine.This instrument panel can also allow to monitor any health care supplier that maybe medicament distribution be given a large amount of patients, perhaps checks one or more and takes program etc.
In addition, can estimate that patient is provided a user interface instrument panel or suchlike device allows patient that prescribed regimen and command information are made amendment according to the present invention.Therefore, illustrate for example, if the user will take a kind of certain drugs before breakfast, the user can confirm when send to the prompting of this medicine.If patient is an early bird, this prompting can be sent at 6:00AM through mobile phone or mail.On the contrary, if patient stays up late and do not have breakfast usually, this prompting can be set at the later time in the morning, thus coupling patient's schedule.Certainly, any this type patient's adjustment must be set in the prescribed regimen of the broad that prescription medical science supplier limited.Can estimate that according to the present invention through touching or user-friendly graphical interfaces, the user can operate many prescription factors easily; And can typing those maybe be to the useful additional information of prescription medical science supplier; Degree of fatigue for example, hunger intensity, vibration imports medicine or the like.All these data collection points allow patient more successfully to take medicine, and more possibly comply with in the prescription rules.
Referring to part shown in Figure 1, the time that horizontal line is represented that patient ingests or otherwise taken medicine.According to the present invention, patient obtains confirming to the compliance of the prescription management arrangement of medicine.According to the present invention, this affirmation possibly need a large amount of forms, and its method for optimizing possibly comprise gathers the actual video program of taking medicine of patient.In further preferable methods, this program that is used to confirm possibly comprise adopting face recognition program or other biological to measure identification confirms whether be that particular patient is being received treatment really.Action recognition, gesture identification or other are used to confirm whether specific experimenter's action meets the characteristic of predetermined action program, possibly be used to all guarantee that patient correctly takes prescription drug.Patient can show medicament reservoir and/or certain pill or other drug form to imaging device then; This imaging device is through user's text identification; Pill identification, or other suitable pharmaceutical recognition mechanisms confirm that medicine is correct and is the current prescription drug that to be ready taking.This series of steps is carried out when taking medicine as audit trail at every turn, also can be used as postmortem, thereby guarantees that patient correctly follows this scheme.
In addition, according to the present invention, thereby patient takes really or the video image of the medicine of ingesting can be taken and store and get off to obtain certain affirmation, rather than it took certain drugs to rely on patient simply.Consider the optional type of action or gesture identification, special embodiment according to the present invention, this video image can be gathered or store by suitable form.Can comprise: complete video; The biometric data point, the moving recording of article (these article for example patient or keeper with bangle etc.), use drawing or other human body mobile trackings technology that the stick figure is provided; Perhaps gesture or other are confirmed the action recognition means of action, or the like.At last, according to the present invention, if can not write down the video that patient takes medicine, system of the present invention will identify this situation and require audio frequency really to select as second.If audio identification is also impossible, also can accept more insecure confirmation method, confirm such as patient's keyboard.If the confirmation method of higher confidence level all can not adopt in a period of time that continues, this system will preferably gives the alarm to the medical expert, inquires reason and this situation of taking that possibly make mistakes is remedied.
These steps of confirming that identity, affirmation medicine and affirmation are taken are all checked the compliance of examining the prescription rules 135.This inspection is preferably carried out through computer system automatically, and this computer system can be compared real recording image and image desirable or expection, and perhaps other actions or the gesture identification through user recited above automatically performs.Technology as for face recognition and bottle or pill identification is techniques well known.Video about the compliance of prescription drug being taken process confirms that this process possibly comprise: various stick figures' comparative analysis, and the action recognition analysis, or whether other affirmation patients recited above have carried out the plan of suitable action.
Compliance to the suitable process of taking provides the ability of automatic affirmation to make these a large amount of images in the short time period, to be examined.Can not 100% under some possible situation confirm even lack compliance really and completely, thus prescreen take that ability that the situation of taking that video will obviously obey gets rid of can reduce basically need be by a large amount of submissiveness situation of medical expert's inspection.
In another embodiment of the present invention, confirm that the imaging application of scheme compliance can further be used for checking bad reaction or other reactions of taking medicine thereby be used to action recognition.Therefore, except confirming the suitable compliance of rules simply, this action or gesture identification also can be confirmed the many different behavior that patient takes.Therefore, take medicine and can understand some specific reactions etc. in depth with behavior afterwards before.Therefore, according to the present invention, before taking medicine, action recognition can be confirmed user's current action.Any prompting of taking medicine subsequently possibly be based in part on the action of this affirmation.For instance; If the user is putting on overcoat, perhaps to confirm to leave residence or other facilities or the like, the medication alert before leaving will be sent; Even than wanting Zao usually; If perhaps medicine is of portable form, the user can be alerted and carry medicine, and takes medicine through the reminder announced on the mobile device subsequently.Further be exemplified as,, will be emitted in the prompting of taking medicine before having a meal if the user cooks.Other situations also are possible, thereby the permission system has more reaction to take medicine suitably to guarantee patient.In addition, according to the present invention, patient's various letters of consent will be by prompting and record.Patient possibly seek advice from the further accessory problem about these letters of consent, thereby guarantees that patient has all information of the informed consent made decision, and guarantees that the medicine supplier has the suitable evidence of these agreements.
Similarly, take medicine behavior afterwards and also can understand the patient reaction in depth.Faint, fall, handicapped, facial expression, the performance of digestive discomfort or the like all can be counted the bad reaction of specific medication scheme, thereby allow after patient's dosage instructed with prescription adjust.If bad reaction is serious, system will provide drug test timely and solve this problem with getting in touch of medical expert.In addition, can directly be connected with pharmacy or medical science supplier's system or cooperation each other according to system of the present invention, thereby make this DM, the suggestion of scheme change or the like is transmitted to these experts automatically.Through these links, the medicine rearrangement, DM, drug replacement etc. can be provided automatically.In addition, because pharmacists or medical science ISP can obtain patient information, drug information and prescription information obtain extra prescription and will become more easy.
Adopting these robotizations, perhaps after robotization and the technology that manually combines, carrying out compliances 140 and confirm, allowing health care supplier or other medical experts inspection and examine the result of automatic comparison, the perhaps direct operation program of being gathered of checking; And needed identity, the variation of medicine or application process possibly require the keeper that this situation is checked, if necessary really will intervening.When being in an emergency, require to carry out this inspection immediately, perhaps some inspection is more not urgent, just possibly require to carry out E-communication with keeper or similar personnel and obtain to advise or other.In addition; This compliance inspection can be given patient and stores according to the time; Thereby allow to confirm various medicine trend; For example, if patient misses medicine in the same time in each week, perhaps indicate certain specific medical care and health personnel who assists patient to give the drug dose that makes mistake aperiodically.Therefore, except allowing the problem in the drug administration notified timely, also formed the audit trail of the behavior that is used to follow the tracks of a plurality of health care suppliers.
Therefore, as shown in Figure 1, according to the invention provides a kind of method and system, wherein patient can obtain inspection to the compliance of prescription drug scheme, is specially adapted to a specific example is perhaps confirmed patient's behavior along with the time any change.Therefore all aspects of this compliance are all preferably visually monitored, and do not rely on the affirmation of patient to drug administration, and person in charge's factor of patient is disallowable, thereby the certain process that can study in drug administration is checked really.
Next with reference to figure 2, to data, the more accurately description of medical record and prescribed regimen inlet will be described in this.As shown in Figure 2, several body can be with the information input according in the system of the present invention.These individualities can comprise doctor 202, and the pharmacists 204, patient 206 and paramedic 208.Each individuality can have data input authority inequality.For example, the doctor possibly have the ability that changes patient information, preclinical medicine statistics and be substantially included in the every other medical information in the database.The pharmacists possibly only limit to import the information about specific prescription, comprises when medicine being distributed to patient, the type of pill or medicine, and the dosage size, the availability of alternative, or the like.Patient possibly only limit to provide personal information, and the relevant information of possible other, such as the use of OTC, and potable spirit, recent symptom, to the reaction of the use of specific prescription drug, or the like.The paramedic possibly only limit to import the information about the patient reaction, the Time of Administration of medicine, or the like.The input of above-mentioned data allows to follow the tracks of is equally taking the audit trail of step.
The information that obtains from each user of system combines in obtainable place, and forms prescription drug inlet 210.Particularly; For system is put in order, the inventory of information preferably at first is provided, according to the present invention if the user is not patient; This information possibly comprise patient name and user's name; And the information that will be used to provide various warnings (such as patient's mail of prescription prompting), doctor or paramedic are used for the contact details of emergency interconnection, or the like.In addition, according to the present invention, patient and other peoples' relevant with system facial image all is stored, perhaps other biological metering identifier, fingerprint recognition for example, retina identification, voice recognition, the various RFID labels that provide, or the like all may be utilized.Certainly, if patient is the secondary treatment, these information can extract from the available data storehouse that stores previous prescription.
Next, the user, for example doctor 202 or pharmacists 204 can provide a specific new or old prescription drug to the user.The user can get into outside drug data base 215; Thereby obtain information, comprise one or more medicine names, if having a plurality of trade names and common name about these medicines; With the patient information is the suggestion of the suitable prescribed dose on basis; And the specific translation of the medicine that will take, to the directions for use that patient provides, these instructions in case of necessity can or replenish by the individual modification of prescription.Above-mentioned directions for use preferably includes the detailed explanation of taking, and comprises the time, patient condition (ante cibum or after meal just, after getting up, before the sleep, or the like), clear and definite method of application, and other are for the useful explanation of user.These explanations also possibly comprise the video program of describing the specific medication details and taking process.Also possibly comprise selectable explanation translation,, thereby can also provide optional a series of explanations to help to improve the compliance of patient to patient to this prescribed regimen if the user is unclear to specific a series of instructions.
After medicine is selected, thereby the medical history taking 217 that preferably gets into patient provides additional medicine and patient information to the prescription individuality, and these information possibly comprise; Thereby other prescriptions of patient are confirmed the spinoff (if other prescriptions are implemented according to the present invention, the native system known should be write out a prescription so) of medicine, the patient's that OTC uses performance; Allergic symptom; Activity level, the disease in past and process, and any maybe the information relevant with drug prescription.
When with all information for after the user input, after accumulating about the information of medicine and patients database, system carries out self-verifying in step 220 pair various drug responses.Thereby make prescription individual notice dangerous interaction stop this prescription entering system.Possibly notice that also these situations can appear in other interaction warning patient thereby prescription is individual.Possibly comprise, for example, two kinds of medicines are taken together possibly cause the warning of having a stomachache, thereby patient is taken with evening respectively in the morning.These interactional inspections cause will a series of explanations being provided to the user except more conventional medicine explanation.At last, the prescription individuality possibly checked these instructions and replenish according to demand.It should be noted that; Can estimate according to the present invention; The various instructions that provide to the user possibly comprise and hot link supplemental audio and visual information; These information possibly be provided for patient with further raising they to the compliance of specific prescription rules, the various information about the specific medication of being taken perhaps possibly are provided, said below as further.
At last, after all interactions and inspection of instruction process and checking, prescription information stores in step 225.The storage of this prescription makes patient and other system user can obtain prescription, alarm and help information etc.In addition, can also prescription be sent to pharmacy or other drug supplying unit, make the user can be easily by the way (swing by) select medicine or medicine handed to patient.
Next with reference to figure 3, user's according to the method for the invention enforcement will be described below.When to the time of accepting or taking medicine, patient and any other user who needs possibly be provided one and notify 310 according to what Notify Address got into aforesaid system.Therefore, if be in, so only patient can receive notice.If the family healthcare supplier, these suppliers possibly also can receive independently affirmation separately.If hospital or other inpatient's care institutions vibrations, each medical science ISP can receive this notice equally.After giving notice, perhaps do not give notice, system starts 315.According to such system start-up, one or more users are preferably recognized by system.Therefore, in step 320, carry out user's recognizer.In a preferred embodiment, the image static or video of this user's face is gathered, and adopts facial recognition techniques to confirm user's identity.This collection can be adopted fixed cameras, mobile camera, mobile communication equipment, mobile phone for example, or any other suitable video or image modalities.Optional recognition technology, such as, except modal cipher inquiry, also can adopt retina, fingerprint, sound or other biological measurement.
In step 325, determine whether that all essential users are all by identification and authentication.The nurse; Doctor or other paramedives distribute under the situation of medicine, thereby make preferably whether patient and paramedic have followed appropriate processes through the further affirmation of the identification of system, and make system log (SYSLOG) make the personnel of medicament; Thereby follow the tracks of; For example, if anyone unsuitable medicine that used, in final audit trail with fairly obvious.After the step 325, if all users are not recognized that all step 320 is got back in the control path, through any other user of system identification.
In case all users through identification, control path to step 327, this moment, prescribed regimen was according to the rules recognized the medicine that will take.Therefore, the user is pointed out and is used image static or video, text identification image; Or the method for other identification medicine is gathered medicine bottle or other containers; Pill, or the medicine of other formulations can also be confirmed suitable quantity; Dosage, and any potential essential or dangerous drug regimen.As stated, if video is confirmed can not carry out for a certain reason, the user can be provided indications audio frequency or other drug and other information that need by system prompt.Then, this image, the affirmation information of video program or other receptions will compare with the relevant image of prescription with aforesaid, as shown in Figure 2.If it is wrong that medicine is determined, will provide medicine incorrect warning to the user.The user can be selected another medicine is carried out to picture then by prompting.
Alternatively, the present invention estimates that the user can show the image collection device with multiple medicine, and making device that which kind of provide is the suggestion of correct medicine.Therefore, the user can use this video imaging apparatus scanning medical cupboard, and making system that which kind of indicate is correct medicine.Quite important when the order of the medicine of ingesting, perhaps take similar medicine and when distinguishing each other medicine and having difficulties, it is very useful that this point is proved to be as two people.In case correct medicine is identified, control path to step 330.
In step 330, to patient, current paramedic user prompt and other instructions are provided, about how to take the instruction of medicine according to above-mentioned prescription guide.This instruction makes the user to receive further information through seek extra help to system.Particularly requiring under the situation of detailed planninng, can estimate that the user possibly obtain the sample and the instruction of video.In addition, according to the present invention, for the process of taking of complicacy; Possibly adopt traditional video conference, VOIP meeting, traditional teleconference; Perhaps any other suitable communication system and expert carry out the two-way video meeting, make paramedic or patient can receive the live telecast instruction about taking.
When following these command prompts, the actual act of taking is preferably gathered in step 335 with video program.The video program of this collection can use in many ways according to the present invention.At first, real-time inspection is carried out in the action of taking medicine, and compare with video program desirable or expectation.If confirm that medicine is taken with the mode of mistake, perhaps take with the mode that patient is harmful to, will cut out immediately give a warning immediately suggestion paramedic or patient of step 340.In addition, under some extreme case, can notify doctor or other paramedives, perhaps under extremely dangerous situation, ambulance or other responding agencies possibly be scheduled for this place nursing timely is provided.If can not obtain videograph, also can adopt aforesaid other confirmation methods, as the videograph program, confirm automatically.
If do not require urgent nursing or warning, control path to step 345 at this moment, is more formally gathered video image, and is used for analyzing various other not dangerous situations.Image can carry out the part to be gathered and stores, and in batch processed, is provided as central server, and perhaps image also can be gathered and send to remote server and be used for analyzing timely and storing.This transmission can connect at whole known network, wireless connections are perhaps carried out in other special-purpose communication systems.This analysis can be offered suggestions to the paramedic and improved the accuracy of dosage, reduces medication pain, or the like.In addition, a large amount of patients and/or paramedic all can obtain this video program, thereby the validity of each series of instructions etc. is tested and checked, if meet with identical problem then change always.If it almost is impossible that such research does not have the present invention, because in the clinical program of any kind, what individuality can be careful when taking medicine is many, therefore can not make mistakes.But, according to the present invention, can analyze reaction to instruction, also can remedy owing to obscuring or be difficult to follow the compliance shortage that instruction causes, better or more available instruction is provided, thus the compliance of improvement project.
In any case, analyze through these, can point out it possibly is problematic instruction area in step 350 generation warning for any warning or the suggestion of instruction.These video programs are if needing also can store in step 355 is used for long-term analysis, and terminal processes.
Further contemplate that according to the present invention its system and method serves as comprehensive prescription management instrument.For example, know the true number of times of the prescription and the medicine of taking, this system can customize the prescription of replacement, and sends to patient.Patient's trend can obtain monitoring; For example patient's blood pressure or other measurable numerical value; And the relation between these measured quantities and the drug administration also can be observed; Make patient can obtain the pharmaceutical admixtures of customization of individual character potentially, can make amendment to the dosage or the frequency of taking based on individual reaction to specific prescribed regimen.In addition, insurance management can be through directly providing prescription information to obtain simplifying to insurance company, thereby through computer network, phone etc. are realized the reparations of patients ' expenses and other bills.In addition, characteristic of the present invention as stated makes user's the movable record of interaction and user, thereby and bad reaction or the like all can be dissolved into and provide further information confirming optional instruction group in the system, the modification of medicine, or the like.
Comprise imaging technique and hardware according to system provided by the present invention; Communication hardware; Comprise storer, be used for the telecommunication of remote storage and analysis, enough realize the computer system of database of patient information and the drug information of aforesaid method through network or other communication networks.
Therefore, according to the present invention, the method and system that provides allows the automatic management of medicine, and is provided for confirming and studying the exact method of the instructions of taking of these prescription drugs.
According to an optional embodiment of the present invention; A kind of system and method is provided; Improve the clinical testing compliance of medical science rules in the works; Give the keeper tangible with mode accurately confirming submissiveness or to lack submissiveness, and the ability of intervening in the process in early days, thus guarantee that the patient who participates in clinical experimental study suitably takes medicine.System and method of the present invention provides about the in test instruction of the use of prescription drug for patient; And patient being provided the affirmation to the compliance of prescription rules Xiang doctor or other ISPs, statistics and the micro-analysis rate of complying with are taken to guarantee suitable clinical testing.This system and method has further improved patient in clinical testing and other nursing levels of accepting in the works, has also improved the view of patient to nursing level simultaneously.System and method of the present invention further provides the ability of following the tracks of clinical testing or other calculated adverse events; Thereby make these incidents to be associated, thereby help the effect and/or the potential danger of specific medication of the object of validation test with other incidents.In addition, this clinical trial management is used the test of being estimated to be equally applicable to medical supply or other devices according to the present invention, and any method of drug administration, comprises and ingesting, injection, local or other suitable medications.
At first, show the data stream overview with reference to figure 4.According to the present invention; Information about the particular medication that becomes the clinical testing object is provided by database 405; Existing industry drug information database 410 is applied to the visit prescription, interacts, and uses; With prescription and OTC about many suggestions, and possible interactional other available informations of they and clinical testing medicine.In addition, use patient's medical record 415, and as as described in following the carrying out with medical record and industry medical information and medical expert's prescription professional knowledge combine with the affirmation patient be so the good person of a clinical testing.In case confirm, the medical science scheme that meets the clinical testing requirement is left and in step 420 input system of the present invention.In case be transfused to system, specific prescribed regimen forms a series of user instructions 425.According to clinical testing, these instructions can change confirming best a series of instructions according to different user, or the factor of the instruction that can possibly require to provide dissimilar according to population distribution, experience or other changes.Further can estimate according to the present invention; Many clinical testings can be managed according to the present invention by the keeper; Make the present invention estimate to form a clinical trial management system, this system allows to carry out single point of management with specific all relevant clinical testings such as keeper.
These user instructions possibly comprise the general remark to current test about the specific medication experimenter; The method of ingesting; Spinoff warning, to common material or medicine, or other are left the worry of the drug response between the medicine by this system or another health care provider.Can estimate that according to the present invention these user instructions can interact, allow the user to browse additional information as required about these instructions or prescription.These instructions can comprise written, instruction audio frequency or video.In addition; Can estimate according to the present invention; Each point in the instruction group is for example inquired the problem of particular type as patient, when perhaps request receives the information about medicine or a certain particular aspects of prescribed regimen; System can offer help and get in touch so that additional individual's help to be provided to patient, if confirm that medical expert's intervention is desirable to patient with medical science ISP delegation where necessary.Therefore, patient can suitably be taken medicine by auxiliary, thereby avoids finding multiple mistake.In fact, in more traditional situations, only possibly and feed back to the doctor there after accomplishing prescribed regimen and could find that medicine is taken by error afterwards according to predetermined clinical testing arrangement.According to the present invention, can be employed to stop about the early intervention of these situations owing to take the possible adverse consequences that medicine brings inadequately, thereby guaranteeing that particular patient is in this research process also provides accurate data for this research.
Can estimate that according to the present invention the keeper of clinical testing provides patient's instrument panel to carry out prescription management for the patient of one or more participation clinical testings, as stated, be used to manage and carry out and by a plurality of clinical testings of cura specialis person's management.This instrument panel allows clinical trial management person with mode described below a large amount of patients to be monitored; Realize patient dependence and patient reaction's statistical study; Link to information is provided; This information comprises the operation program to one or more patients' record, record and the occurent in test any bad reaction of notice, and roughly allow the medical expert all test participants to be monitored and manage from single easily access port.This instrument panel can also allow to monitor maybe medicament distribution given a large amount of clinical testing participants or checked one or more takes any health care supplier of program, or the like.
In addition; Can estimate according to the present invention; Patient is provided a user interface instrument panel or suchlike device is made amendment to prescribed regimen and command information to allow patient, only limits to certainly within the guide that prescription medical science supplier sets up, make amendment.Therefore, illustrate for example, if the user will take a kind of certain drugs before breakfast, the user can confirm when the prompting of this medicine sends.If patient is an early bird, this prompting can be sent at 6:00AM through mobile phone or mail.On the contrary, if patient stays up late and do not have breakfast usually, this prompting can be set at the later time in the morning, thus coupling patient's schedule.Certainly, any this type patient's adjustment must be arranged in the prescribed regimen scope of the broad that prescription medical science supplier limits.These modifications that are asked to can provide the additional information about the simpler rules of drug administration to trial person, perhaps can guide the non-compliance of the testing regulations of specific individuality is examined.
Can estimate that according to the present invention through touching or user-friendly graphical interfaces, the user can operate many prescription factors easily; And can typing those maybe be to the useful additional information of prescription medical science supplier; Degree of fatigue for example, hunger intensity, vibration imports medicine or the like.All these data collection points allow patient more successfully to take medicine, and more possibly comply with in the prescription rules.
Referring to lower part shown in Figure 4, the time that horizontal line is represented that patient ingests or otherwise taken medicine.Patient can show medicament reservoir and/or certain pill or other drug form to imaging device then; This imaging device is through user's text identification; Pill identification, or other suitable pharmaceutical recognition mechanisms confirm that medicine is correct and is the current prescription drug that to be ready taking.This series of steps is carried out when taking medicine as audit trail at every turn, also can be used as postmortem, thereby guarantees that patient correctly follows this scheme.
According to the present invention, patient obtains confirming to the compliance of the medicine of prescription management arrangement.According to the present invention, this affirmation possibly carried out in a variety of forms, and its method for optimizing possibly comprise gathers the actual video program of taking medicine of patient.In further preferable methods; This program that is used to confirm possibly comprise adopting face recognition program or other biological to measure identification confirms whether be that particular patient is being received treatment really; But the ability of facial or other the special characteristics that can blur the user can be provided also; Thereby protection user's identity when storing and using these images a kind ofly provides about the symposium of this clinical testing and the technology of situation about need not remedy to particular patient as the keeper.Action recognition, gesture identification or other are used to confirm the characteristic whether specific experimenter's action meets the predetermined action program, possibly be used to all guarantee that patient correctly takes prescription drug.
In addition, according to the present invention, thereby patient takes really or the video image of the medicine of ingesting can be taken and store and get off to obtain certain affirmation, rather than it took certain drugs to rely on patient simply.Consider the optional type of action or gesture identification, special embodiment according to the present invention, this video image can be gathered or store by suitable form.Can comprise: complete video; The biometric data point; The moving recording of article (these article for example patient or keeper with bangle etc.), use drawing or other human body mobile trackings technology that the stick figure is provided, perhaps gesture or other are confirmed the action recognition means of action etc.The user can be encouraged to use specific mobile process correctly to take medicine to confirm them according to rules, thereby has reduced the possibility of potential suitable mobile being considered to " correctly ".In fact, can provide various instruction images or other suitable trainings correctly to take medicine to the user to guarantee them.At last, according to the present invention, if can not write down the video that patient takes medicine, system of the present invention will identify this situation and require audio frequency really to select as second.If audio identification is also impossible, also can accept more insecure confirmation method, confirm such as patient's keyboard.If the confirmation method of higher confidence level all can not adopt in a period of time that continues, this system will preferably give the alarm to the medical expert, remedies with the inquiry reason and to this situation of taking that possibly make mistakes.
These steps of confirming that identity, affirmation medicine and affirmation are taken are all checked the compliance of examining the prescription rules 435.This inspection is preferably carried out through computer system automatically, and this computer system can be compared real recording image and image desirable or expection, and perhaps other actions or the gesture identification through user recited above automatically performs.Technology as for face recognition and bottle or pill identification is techniques well known.Video about the compliance of prescription drug being taken process confirms that this process possibly comprise: various stick figures' comparative analysis, and the action recognition analysis, or whether other affirmation patients recited above have carried out the plan of suitable action.
Provide the ability of the automatic affirmation of the compliance that correct takes process to make these a large amount of images in the short time period, to be examined.Can not 100% under some possible situation confirm even lack compliance really and completely, thus prescreen take that ability that the situation of taking that video will obviously obey gets rid of reduced basically need be by a large amount of submissiveness situation of medical expert's inspection.Extra hand inspection to the instruction of compliance failure can be provided, thereby guarantee that when reduction needs the quantity of the image of hand inspection greatly all potential unsafe conditions are by suitably inspection.Therefore, this automatic system has realized multiple benefit, when having improved quality, has reduced the time of checking these images, has reduced the expense of these inspections, has improved patient's the right of privacy through crowd's quantity of these data of restriction inspection.
In another embodiment of the present invention, confirm that the imaging application of scheme compliance can further be used for checking bad reaction or other reactions of taking medicine thereby be used to action recognition.Therefore, except confirming the suitable compliance of rules simply, this action or gesture identification also can be confirmed the many different behavior that patient takes.Therefore, take medicine and can understand some specific reactions etc. in depth with behavior afterwards before.Therefore, according to the present invention, before taking medicine, action recognition can be confirmed user's current action.Any prompting of taking medicine subsequently possibly be based in part on the action of this affirmation.For instance; If the user is putting on overcoat, perhaps to confirm to leave residence or other facilities or the like, the medication alert before leaving will be sent; Even than wanting Zao usually; If perhaps medicine is of portable form, the user can be alerted and carry medicine, and takes medicine through the reminder announced on the mobile device subsequently.Further be exemplified as,, will be emitted in the prompting of taking medicine before having a meal if the user cooks.Other situations also are possible, thereby the permission system has more reaction to take medicine suitably to guarantee patient.In addition, according to the present invention, patient's various letters of consent will be by prompting and record.Patient possibly seek advice from the further accessory problem about these letters of consent, thereby guarantees that patient has all information of the informed consent made decision, and guarantees that the medicine supplier has the suitable evidence of these agreements.
Similarly, take medicine behavior afterwards and also can understand the patient reaction in depth.Faint, fall, handicapped, facial expression, the performance of digestive discomfort or the like all can be counted the bad reaction of specific medication scheme, thereby allow after patient's dosage instructed with prescription adjust.If bad reaction is serious, system will provide drug test timely and solve this problem with getting in touch of medical expert.In addition, can directly be connected with pharmacy or medical science supplier's system or cooperation each other according to system of the present invention, thereby make this DM, the suggestion of scheme change or the like is transmitted to these experts automatically.Through these links, the medicine rearrangement, DM, drug replacement etc. can be provided automatically.In addition, because pharmacists or medical science ISP can obtain patient information, drug information and prescription information obtain extra prescription and will become more easy.
Adopting these robotizations, perhaps after robotization and the technology that manually combines, carrying out compliances 440 and confirm, allowing health care supplier or other medical experts inspection and examine the result of automatic comparison, the perhaps direct operation program of being gathered of checking; And needed identity, the variation of medicine or application process possibly require the keeper that this situation is checked, if necessary really will intervening.When being in an emergency; This inspection can be required to carry out immediately when perhaps patient wants help through gesture or other action signals; Perhaps this inspection possibly be more not urgent, just possibly require to carry out E-communication with keeper or similar personnel and obtain to advise or other.In addition; This compliance inspection can be given patient and stores according to the time; Thereby allow to confirm various medicine trend; For example, if patient misses medicine in the same time in each week, perhaps indicate certain specific medical care and health personnel who assists patient to give the drug dose that makes mistake aperiodically.Therefore, except allowing the problem in the drug administration notified timely, also formed the audit trail of the behavior that is used to follow the tracks of a plurality of health care suppliers.This audit trail makes that clinical trial management person or other medical experts can be immediately; Perhaps after, confirm whether particular patient or patient group are followed scheme and arrived that to a certain degree make can be with their result as the part of research to the inspection of complete pharmaceutical admixtures.In addition, the compliance level can be understood the use difficulty or ease (ease of use) of specified scheme in depth, and whether the instruction that offers patient has considered the compliance to the prescription drug scheme sufficiently.
Therefore; As shown in Figure 4; According to the invention provides a kind of method and system, wherein patient's compliance to the prescription drug scheme in the clinical testing sight can obtain inspection, is specially adapted to a specific example is perhaps confirmed patient's behavior along with the time any change.Therefore all aspects of this compliance are all preferably visually monitored, and do not rely on the affirmation of patient to drug administration, and person in charge's factor of patient is disallowable, thereby the certain process that can study in drug administration is checked really.Therefore trial person can make patient continue their prescribed regimen; Thereby reduce the full payment relevant, thereby comply with when prescribed regimen reduces accuracy of experimental results with repeatability patient is gone into the crowd to get rid of from test when patient can not keep with clinical testing.Through the management to a plurality of clinical testings, patient's interaction is eased, and respectively any similarity between the test also can obtain confirming, thereby improves the quality of nursing basically, and guarantees a large amount of consistance of testing.
Next with reference to figure 5, the more accurately description that data, medical record and prescribed regimen are entered the mouth will be described in this.As shown in Figure 5, clinical trial management person 502 imports system of the present invention with information, particularly imports the information about pharmaceutical admixtures, dosage, instruction group or the like.Patient 506 can also import the information relevant with patient.Trial person 502 can further import or change patient information, preclinical medicine data and the actual every other medical information that is included in the database.Patient 506 possibly only limit to provide personal information, and maybe other relevant information, such as the use of OTC, and potable spirit, recent symptom, to the reaction of the use of specific prescription drug, or the like.Certainly, any this information can be from database of having logined in advance or the region of data storage automatic input system that have earlier.And, if information specific is omitted by patient, perhaps can not obtain, might require this information of standard, perhaps patient is got rid of from clinical testing.In addition, the affirmation of the normal processes of information collector failure can be used to confirm, makes the inadequate patient of information gathering before getting into clinical testing, add and trains or be excluded.
The information that obtains from each user of system combines in obtainable place, and forms clinical testing medicine inlet 510.Particularly, for system is put in order, the inventory of information is provided at first preferably according to the present invention; If the user is not patient, possibly comprises patient name and user's name, and will be used to provide various warnings; The information of patient's mail of reminding such as writing out a prescription, doctor or paramedic are used for the contact details of emergency interconnection, for the email address of various high capacity or non-emergent interchange; And the mobile phone or the landline telephone that are used for patient link, or the like.To trial person 502 provide further notice make the keeper can monitor patients to medicine use and to compliance suggestion or that prescription drug is taken.In addition; According to the present invention, patient and other peoples' relevant with system facial image all is stored, perhaps other biological metering identifier; Fingerprint recognition for example; Retina identification, voice recognition, the various RFID labels that provide etc. all can be combined more traditional passwords and user's name or the like mode to use.Certainly, if patient is the secondary treatment, these information can extract from the available data storehouse that stores previous prescription.
Next, the user, for example doctor 502 or pharmacists 504 or nurse can provide a specific new or old prescription drug to the user according to this clinical testing.The user can get into outside drug data base 515; Thereby obtain information about these medicines; Comprising medicine name, is the suggestion of the suitable prescribed dose on basis with the patient information, and the specific translation that will take medicine; To the directions for use that patient provides, these instructions in case of necessity can be revised or replenish by trial person.These directions for uses preferably include the detailed explanation of taking, and comprise the time, patient condition (ante cibum or after meal just, after getting up, before the sleep, or the like), clear and definite method of application, and other are for the useful explanation of user.Thereby these explanations also possibly comprise the specific detail of describing medicine and take the action that the video program of process suitably indicates patient to carry out.These explanations also possibly comprise selectable explanation translation, if the user is unclear to specific a series of instructions, thereby also possibly provide optional a series of explanations to help to improve the compliance of patient to this prescribed regimen to patient.
After medicine is selected, thereby the medical history taking 517 that preferably gets into patient provides additional medicine and patient information to trial person, and these information possibly comprise; Thereby other prescriptions of patient are confirmed the spinoff (if other prescriptions are implemented according to the present invention, the native system known should be write out a prescription so) of medicine, the patient's that OTC uses performance; Allergic symptom; Activity level, the disease in past and process, and any maybe the information relevant with drug prescription.
When with all information for after the user input, after accumulating about the information of medicine and patients database, system carries out self-verifying in step 520 pair various drug responses.Thereby make trial person notice dangerous interaction stop this prescription entering system, and this clinical testing of prevention particular patient participation.Thereby trial person also possibly notice other interaction warning patient and these situations can occur.Possibly comprise, for example, two kinds of medicines are taken together possibly cause the warning of having a stomachache, thereby patient is taken with evening respectively in the morning.These interactional inspections cause will a series of explanations being provided to the user except more conventional medicine explanation.At last, trial person possibly check these instructions and replenish according to demand.It should be noted that; Can estimate according to the present invention; The various instructions that provide to the user possibly comprise and hot link supplemental audio and visual information; These information possibly be provided for patient and further improve their compliance to specific prescription rules, and the various information about the specific medication of being taken perhaps possibly are provided, and are said below as further.These instructions can indicate the method that the user takes a kind of or more kinds of medicines, thus request certain gestures and other use in taking.
At last, after all interactions and inspection of instruction process and authentication, prescription information stores in step 525.The storage of this prescription makes patient and other system user can obtain alarm, help information, or the like.In addition, can also prescription be sent to pharmacy or other drug supplying unit, make the user can select medicine easily by the way and perhaps medicine is handed to patient.
Next with reference to figure 6, user's according to the method for the invention enforcement will be described below.When to the time of accepting or taking medicine, patient and any other user who needs can be provided one and notify 610 according to what Notify Address got into aforesaid system.Therefore, if be in, so only patient can receive notice.If the family healthcare supplier, these suppliers possibly also can receive independently affirmation separately.If hospital or other inpatient's care institutions vibrations, each medical science ISP can receive this notice equally.After giving notice, perhaps do not give notice, system starts 615.According to such system start-up, one or more users are preferably by system identification.Therefore, in step 620, carry out user's recognizer.In a preferred embodiment, the image static or video of this user's face is gathered, and adopts facial recognition techniques to confirm user's identity.This collection can be adopted fixed cameras, mobile camera, mobile communication equipment, mobile phone for example, or any other suitable video or image modalities.Optional recognition technology, such as, except modal cipher inquiry, also can adopt retina, fingerprint, sound or other biological measurement.When image is used as about compliance but not during the general report of individual patient reaction, any other suitable recognition technology all may be utilized, any unique individual indications is fallen in covering simultaneously, as stated.
In step 625, determine whether that all essential users are all by identification and authentication.The nurse; Doctor or other paramedives distribute under the situation of medicine, thereby make preferably whether patient and paramedic have followed appropriate processes through the further affirmation of the identification of system, and make system log (SYSLOG) make the personnel of medicament; Thereby follow the tracks of; For example, if anyone unsuitable medicine that used, in final audit trail with fairly obvious.After the step 625, if all users are not recognized that all step 620 is got back in the control path, through any other user of system identification.
In case all users through identification, control path to step 627, this moment, prescribed regimen was according to the rules recognized the medicine that will take.Therefore, the user is pointed out and is used image static or video, text identification image; Or the method for other identification medicine is gathered medicine bottle or other containers; Pill, or the medicine of other formulations can also be confirmed suitable quantity; Dosage, and any potential essential or dangerous drug regimen.As stated, if video is confirmed can not carry out for a certain reason, the user can be provided indications audio frequency or other drug and other information that need by system prompt.Then, this image, the affirmation information of video program or other receptions will compare with the relevant image of prescription, as shown in Figure 5.If it is wrong that medicine is determined, will provide medicine incorrect warning to the user.The user can be selected another medicine is carried out to picture then by prompting.
Alternatively, the present invention estimates that the user can show the image collection device with multiple medicine, and making device that which kind of provide is the suggestion of correct medicine.Therefore, the user can use this video imaging apparatus scanning medical cupboard, and making system that which kind of indicate is correct medicine.Quite important when the order of the medicine of ingesting, perhaps take similar medicine and when distinguishing each other medicine and having difficulties, it is very useful that this point is proved to be as two people.In case correct medicine is identified, control path to step 630.
In step 630, to patient, current paramedic user prompt and other instructions are provided, about the instruction of how to take medicine according to the above-mentioned prescription guide of confirming in the clinical testing under consideration.This instruction makes the user can receive further information or instruction through seek extra help to system in case of necessity.Particularly requiring under the situation of detailed planninng, can estimate that the user possibly obtain the sample and the instruction of video.In addition, according to the present invention, for the management process of complicacy; Possibly adopt traditional video conference, VOIP meeting, traditional teleconference; Perhaps any other suitable communication system and expert carry out the two-way video meeting, make paramedic or patient can receive the live telecast instruction about taking.Thereby these instructions and prompting can provide success or the failure of confirming the specific instruction group by clinical trial management person.Therefore; DO need not tested in clinical testing, thereby the instruction group also need test to confirm which kind of is best for everyone, or for demography group or the like; Or for final user when medicine is provided to the public, thereby realize the public's better compliance.Along with the growth of clinical testing quantity, the place of these tests becomes and internationalizes more, will become more important through a plurality of clinical trial management persons of system management according to the present invention.
When following these command prompts, the actual act of taking is preferably gathered in step 635 with video program.Therefore this is taken and preferably includes one or more discernible gestures that instruction as described above is advised.Therefore, patient or keeper possibly be provided one or more images or the program for application or instructions of taking, thereby ensuing these programs are used for confirming the compliance to specific prescribed regimen.In addition, the long-time or keeper that can be confirmed as feasible test participant that pauses further understands the zone of bringing problem in depth.The video program of this collection can use in many ways according to the present invention.At first, real-time inspection is carried out in the action of taking medicine, and compare with video program desirable or expectation.If confirm that medicine is taken with the mode of mistake, perhaps take with the mode that patient is harmful to, will cut out immediately give a warning immediately suggestion paramedic or patient of step 640.In addition, under some extreme case, can notify doctor or other paramedives, perhaps under extremely dangerous situation, ambulance or other responding agencies possibly be scheduled for this place nursing timely is provided.Notice also possibly be provided for clinical trial management person, warns its one or more patients that there is the compliance problem in these rules.If this problem is proved to be independently, optional instruction or individual help all can remedy this state, thereby make patient to test significant data are provided.If generally lack compliance, clinical trial management person possibly change instruction for all participants, perhaps even ask all participants to return to accept further on-the-spot instruction.Under any one situation,, cause the research failure to be avoided owing to lack the rules compliance, so the expense of clinical testing reduce greatly because the participant all can keep under study for action.Do not comprise the image of identity characteristic etc. through employing, can be provided for the keeper, make this report accurately show privacy and the secret of having protected patient when medicine is how to take based on this report that generally lacks compliance.If can not obtain videograph, also can adopt aforesaid other confirmation methods, as the videograph program, confirm automatically.
If do not require urgent nursing or warning, control path to step 645 at this moment, is more formally gathered video image, and is used for analyzing various other not dangerous situations.Image can carry out the part to be gathered and stores, and in batch processed, serves as central server, and perhaps image also can be gathered and send to remote server and be used for analyzing timely and storing.This transmission can connect at whole known network, wireless connections are perhaps carried out in other private communication systems.This analysis can consider to propose to improve to the paramedic accuracy of dosage, reduces medication pain, or the like suggestion.Before medicine was distributed to the public, these suggestions can be converted into various instructions or training program.In addition, participate in patients current or a plurality of clinical testings and/or paramedic in a large number and all can obtain this video program, thereby the validity of various series of instructions etc. is tested and checked, if meet with identical problem then change always.If such research does not have the present invention almost can not carry out, because in the clinical protocol of any kind, what individuality can be careful when taking medicine is many, therefore can not make mistakes.When they returned in to the home or get back in the life clocklike, Here it is proposed the opportunity of compliance kimonos with matters.According to the present invention, can analyze reaction to instruction, also can remedy owing to obscuring or be difficult to follow the compliance deficiency that instruction causes, better or more available instruction is provided, thus the compliance of improvement project.Do not have the present invention, clinical trial management person possibly just not know these matters.Because in a single day just can be notified appears in existence of the present invention, these matters, thereby guarantee the integrality of clinical testing.
In any case, analyze through these, can point out it possibly is problematic instruction area in step 650 generation warning for any warning or the suggestion of instruction.These video programs are if needing also can store in step 655 is used for long-term analysis, and terminal processes.In addition, maintain in the clinical testing in order to encourage patient, the notice that lacks compliance can be used to change the remuneration that patient receives in clinical testing.Therefore, make patient obtain higher remuneration, in scheme bigger power is provided for the patient compliance to the compliance of scheme.
The trend of participating in the patient of this clinical testing can obtain monitoring; For example patient's blood pressure or other measurable numerical value; And the relation between these measured quantities and the drug administration also can be observed; Make patient can obtain the pharmaceutical admixtures of customization of individual character potentially, can make amendment to the dosage or the frequency of taking based on individual reaction to specific prescribed regimen.In addition, characteristic of the present invention as stated makes user's the movable record of interaction and user, thereby and bad reaction or the like all can be dissolved into and provide further information confirming optional instruction group in the system, the modification of medicine, or the like.
Further estimate that this clinical trial management person is provided keeper's instrument panel to realize the inspection that gathers to all patients of participating in one or more clinical testings.The details of the example embodiment of this instrument panel will be described following, referring to Fig. 7-9.As shown in Figure 7, the page that gathers of instrument panel is depicted as 700.Each different clinical test estimates to have one or more pages (consider participant's quantity, it possibly be necessary that the page exceeds one page) that gather for some specific clinical testing.Each summary page face comprises the designator 710 of participating in all participants of particular clinical trial to each.Designator among Fig. 7 is depicted as people of each icon indication.The also replaceable one-tenth of these icons gathers identifying information etc., perhaps any other desirable designator, for example the demography designator (that is, and age group, sex, medical condition, idiosyncrasy, or the like).Also has the designator legend that comprises the information that goes for any one or a plurality of designator 710 on the instrument panel 700.In a certain preferred embodiment of the present invention; This designator legend comprises indicator mark, this mark indication: seeked advice from problem or required for one and report out lower submissiveness to the special test participant that some instruction or other aspects of clinical testing carried out setting forth.As shown in the figure, each indicator mark can be applied to specific designator 710 and carry out mark with sign.Therefore, as shown in Figure 7, designator 712 is marked as bad submissiveness, and designator 714 is marked as counseling problem.Therefore, by this way, make clinical trial management person can scan the patient condition in the clinical testing.Clinical trial management person can confirm most of submissiveness problems easily through browsing instrument panel, has the designator 710 that is modified as bad submissiveness by indicator mark on this instrument panel.Similarly, if gather a large amount of problem of demonstration on the page or set forth request so the problem of this instruction possibly be fairly obvious.Certainly, also indicator mark can be provided for a large amount of other problemses.The statistical study of clinical testing colony also can be provided, thereby allows clinical trial management person to confirm the integral body of this clinical testing colony or the compliance ratio and other indexs of segmentation.This mark is preferably color indicator, comprises that also any other suitable designator makes clinical trial management person confirm state.
Instrument panel 700 further preferably includes the convergent-divergent designator; Thereby thereby the patient who allows clinical trial management person to narrow down to each patient or lesser amt watches their comprehensive submissiveness statistics; Perhaps watch the video program of record; To additional information, or the request of stored any other information of the audit trail that is used for patient according to the present invention.Therefore, if the convergent-divergent designator narrows down to minimum, clinical trial management person can observe the designator 710 of maximum number on the instrument panel.The moderate convergent-divergent preferably provides window as shown in Figure 8 to clinical trial management person.As shown in the figure, designator 712 comprises the information adjacent with designator.In the situation of being showed, also show the title of indicator mark.This point is useful when a large amount of indicator mark are provided.Alternatively, the text can comprise the most critical part of information, perhaps the information picked out of user.This zoom feature also possibly allow clinical trial management person to dwindle through similar population demographic information, thereby watches representative has the clinical testing participant of similar characteristics with one or more forms designator 710.
In addition, can estimate that clinical trial management person can use gathers instrument panel, with any desirable convergent-divergent degree the subclass that is included in the designator in the clinical testing is selected, moves, is revised or operation.Therefore, one or more participants can be assigned to different colonies as required and organize to receive different instructions, and dosage perhaps carries out any other modification of drug administration to selected participation group.The participant also can be considered to the useful mode of clinical trial management person is divided into groups according to prescription medical science supplier, clinic, medical science group, insurance company or any other.Through grouping, might confirm it whether is the bad compliance that any specific clinic, doctor or the like cause this group to these groups.Therefore, relevant with particular group bad compliance also can be handled through the additional training to clinic or doctor.The participant can be added in the research of special test or other epidemiological studies etc., or from wherein rejecting, if desired, perhaps carries out other operations.Dividing into groups also can be automatically, for example with all patients through the age, sex, perhaps other Demographics are divided into groups, thereby useful fast view are provided for clinical trial management person.
Further zoom to single designator, make clinical trial management person watch the more designator of peanut.Along with the decline of the quantity of designator, the quantity of information of each designator that clinical trial management person obtained is many more.Therefore, clinical trial management person can zoom to each possible degree as shown in Figure 9.As shown in Figure 9, first zoom degree shows the extent of information of Fig. 8, and this moment, a large amount of designators 710 remained visible.A more detailed zoom degree preferably illustrates.Identical bad submissiveness designator, but further showing this bad submissiveness relates to the short supply of medicine schedule, particularly medicine, thus the more complete compliance inspection to the clinical testing participant is provided.(or suggestion) training video because that the participant does not also check is necessary, and the 5th step in the affirmation scheme that limits have any problem, this information further provides the information by the participant's of this indicator representing bad submissiveness.At last; In order to understand more information about bad submissiveness; This designator is carried out further convergent-divergent; This participant is shown only has only 7% behavior to confirm through video, 10% confirms through sound, and remaining 83% confirms (this gui interface depend on patient therefore be considered to be not so good as other two kinds of method that kind credible) through gui interface.In addition, this participant seeked advice from a specific problem.According to this specific convergent-divergent degree, estimate that clinical trial management person may be directly connected to the information that video, audio frequency or the GUI of storage provide.Preferably, clinical trial management person is provided a time shaft, and this time shaft indicates various, video, audio frequency and/or GUI input when be stored.This clinical trial management person can observe the more useful picture of compliance program, and the program that can pick out any one storage then is used for inspection.This keeper can also answer query, perhaps problem is pass on to the doctor or the similar personnel that are suitable for answering this problem.This clinical trial management person can also select to change the instruction that is provided for one or more patients according to the record of the compliance after carrying out first series of instructions.This zoom degree can also provide to the participant and allow to exchange with particular participant, and the method for the additional training of suggestion, instruction or help, and the link of ordering or provide the program of medication.Can also check the special instruction to patient that patient provides, parameter is selected, perhaps comment or the like.At last, clinical trial management person can check the prescription information that is about to send, and comprises the number of times of taking the prescription or being applicable to one or more patients' other drug.
Therefore through such instrument panel, clinical trial management person can receive the notice of any problematic failure of intervening about patient's warning, or directly contact, and change scheme or instruction are perhaps recalled patient and retrained.As stated; Need not wait for that patient returns and report bad compliance; Perhaps worse situation; Make patient's data become the part of the data of clinical effectiveness, even have bad compliance, this clinical trial management person can use instrument panel of the present invention to guarantee that bad submissiveness is by EARLY RECOGNITION and processing.In addition, emergency can indicate to clinical trial management person immediately.
This instrument panel preferably has the patient's except above-mentioned notification feature the characteristics of management.Therefore, this clinical trial management person can manage individual participant through functional click and/or drag operation, colony's subclass, and perhaps whole colony can propagate information to these groups as required, comprises transmit video, text or sound instruction.The also preferred participant of prompting of this clinical trial management person doctor on the horizon preengages, and about the meeting of clinical testing, this notice can also be provided to patient's prescriber.In case notify participant's medicine to use up, perhaps only through the actual medicine of taking of track participant, for the participant provides extra medicine or goods and materials.Therefore, without any need for conjecture.This keeper can check as required further that thereby patient's medical record further improves the submissiveness of process of the test.
This instrument panel also preferably provides the medical expert's relevant with one or more clinical testing participants inlet.This test provides under all prescription doctor or other medical supervision persons' the situation to those patients that possibly want help; This characteristic possibly be unessential; But, can provide information can be proved to be very valuable to these doctors with exchanging each other when a plurality of prescription doctors have all participated in test.This contact can relevant with each patient identifier symbol icon link or connect realization through what provided on the instrument panel.Therefore, this clinical trial management person can check video or other compliance marks with such prescriber, and any complication that patient possibly occur in process of the test is carried out long-range classification, perhaps requires to write out a prescription replacing, or the like.In addition, this clinical trial management person can take medicine in the treatment of after this examining the medical expert and according to prescription clinical testing process.Through this audit, this keeper can confirm the relevant matters of action with the specific personnel that take.
User's instrument panel can be provided as allowing participant's input information, and the submissiveness information of for example above-mentioned GUI input can also be putd question to, and checks additional instruction, orders goods and materials or the like.The user can also check more specific prescribed regimen information, and when for example next medicine is predetermined takes, or provides a calendar to be used for the predetermined time period in the future to realize prospective project.Through such user's instrument panel, the user can check the information specific relevant with their treatment, but preferred these information are not enough to influence their participation to test.If in use, the participant can also check according to the present invention whether they have accomplished and can cause the various compliance degree paid.In addition, the user can be provided definite method that a kind of data transmit degree, comprises the identity information that the keeper as various degree provides.Therefore, when all information after clinical trial management person provides, may more limited identifying information be provided to other researchists or similar personnel.This participant can potentially be used by notice, select to get into or selects to withdraw from a series of selections and realize disclosing in various degree.The user can be provided privacy designator is set, and indicates the obtaining degree of information recorded and additional identifying information thereof.
Therefore, this instrument panel confirms that with exercisable clinical testing the system of program and above-mentioned light use combines, and has increased validity and has allowed this clinical testing is better controlled.Following the difficulty of rules can almost confirm in real time.The change of test can easily realize and pass on to test participant and their prescription doctor.New training module, thus comprising that video, text or other instructions can provide in test improves compliance.Inventory management is more easy, and all test participants are guaranteed to have the suitable consumption of medicine and other goods and materials.In addition, keep omnidistance audit to follow the trail of and visited any particular patient, patient group, or the information of one or more clinical testings.But this instrument panel is not limited in clinical testing and uses.This system also can be by a medical science supplier, doctor's group or network, insurance company, government organs, nursing home, poorhouse, family health care supplier or the like; Perhaps other groups are used, thereby follow the tracks of a large amount of patients and relevant residential care personnel, doctor or other drug keeper.Under this situation; Watching, dividing into groups and retrieve the better control that allows patient the important information of given patient; Thereby reduced patient and continued to take wrong medicine; Perhaps take the possibility of these medicines by error, thereby reduced bad reaction or dead possibility that specific medication causes successively.
Comprise imaging technique and hardware according to system provided by the present invention; Communication hardware; Comprise storer, be used for the telecommunication of remote storage and analysis, enough realize the computer system of database of patient information and the drug information of aforesaid method through network or other communication networks.All communications are all to have carried out encrypting or other protections in this locality or the long-range a plurality of storage unit time transmitting or being stored in, to meet the desired any regulation of security matters and storage and maintenance medical science and patient medical healthcare information.
Therefore, allow the automatic affirmation of the compliance of the rule of management of medicine in the clinical testing environment, and be provided for confirming and studying the exact method of the instructions of taking of these prescription drugs according to method and system provided by the present invention.
According to an optional embodiment of the present invention; A kind of system and method is provided; Improve the clinical testing compliance of medical science rules in the works; Give the keeper tangible with mode accurately confirming submissiveness or to lack submissiveness, and the ability of intervening in the process in early days, thus guarantee that the patient who participates in clinical experimental study suitably takes medicine.System and method of the present invention provides about the in test instruction of the use of prescription drug for patient; And patient being provided the affirmation to the compliance of prescription rules Xiang doctor or other ISPs, statistics and the micro-analysis rate of complying with are taken to guarantee suitable clinical testing.This system and method has further improved patient in clinical testing and other nursing levels of accepting in the works, has also improved the view of patient to nursing level simultaneously.System and method of the present invention further provides the ability of following the tracks of clinical testing or other calculated adverse events; Thereby make these incidents to be associated, thereby help the effect and/or the potential danger of specific medication of the object of validation test with other incidents.In addition, this clinical trial management is used the test of being estimated to be equally applicable to medical supply or other devices according to the present invention, and any method of drug administration, comprises and ingesting, injection, local or other suitable medications.
At first, show the data stream overview with reference to Figure 10.According to the present invention; Information about the particular medication that becomes the clinical testing object is provided by database 1005; Existing industry drug information database 1010 is applied to the visit prescription, interacts, and uses; With prescription and OTC about many suggestions, and possible interactional other available informations of they and clinical testing medicine.In addition, use patient's medical record 1015, and as as described in following the carrying out with medical record and industry medical information and medical expert's prescription professional knowledge combine with the affirmation patient be so the good person of a clinical testing.In case confirm, the medical science scheme that meets the clinical testing requirement is left and in step 1020 input system of the present invention.In case be transfused to system, specific prescribed regimen forms a series of user instructions 1025.According to clinical testing, these instructions can change confirming best a series of instructions according to different user, or the factor of the instruction that can possibly require to provide dissimilar according to population distribution, experience or other changes.Further can estimate according to the present invention; Many clinical testings can be managed according to the present invention by the keeper; Make the present invention estimate to form a clinical trial management system, this system allows to carry out single point of management with specific all relevant clinical testings such as keeper.
These user instructions possibly comprise the general remark to current test about the specific medication experimenter; The method of ingesting; Spinoff warning, to common material or medicine, or other are left the worry of the drug response between the medicine by this system or another health care provider.Can estimate that according to the present invention these user instructions can interact, allow the user to browse additional information as required about these instructions or prescription.These instructions can comprise written, instruction audio frequency or video.In addition; Can estimate according to the present invention; Each point in the instruction group is for example inquired the problem of particular type as patient, when perhaps request receives the information about medicine or a certain particular aspects of prescribed regimen; System can offer help and get in touch so that additional individual's help to be provided to patient, if confirm that medical expert's intervention is desirable to patient with medical science ISP delegation where necessary.Therefore, patient can suitably be taken medicine by auxiliary, thereby avoids finding multiple mistake.In fact, in more traditional situations, only possibly and feed back to the doctor there after accomplishing prescribed regimen and could find that medicine is taken by error afterwards according to predetermined clinical testing arrangement.According to the present invention, can be employed to stop about the early intervention of these situations owing to take the possible adverse consequences that medicine brings inadequately, thereby guaranteeing that particular patient is in this research process also provides accurate data for this research.
Can estimate that according to the present invention the keeper of clinical testing provides patient's instrument panel to carry out prescription management for the patient of one or more participation clinical testings, as stated, be used to manage and carry out and by a plurality of clinical testings of cura specialis person's management.This instrument panel allows clinical trial management person with mode described below a large amount of patients to be monitored; Realize patient dependence and patient reaction's statistical study; Link to information is provided; This information comprises the operation program to one or more patients' record, record and the occurent in test any bad reaction of notice, and roughly allow the medical expert all test participants to be monitored and manage from single easily access port.This instrument panel can also allow to monitor maybe medicament distribution given a large amount of clinical testing participants or checked one or more takes any health care supplier of program, or the like.
In addition; Can estimate according to the present invention; Patient is provided a user interface instrument panel or suchlike device is made amendment to prescribed regimen and command information to allow patient, only limits to certainly within the guide that prescription medical science supplier sets up, make amendment.Therefore, illustrate for example, if the user will take a kind of certain drugs before breakfast, the user can confirm when the prompting of this medicine sends.If patient is an early bird, this prompting can be sent at 6:00AM through mobile phone or mail.On the contrary, if patient stays up late and do not have breakfast usually, this prompting can be set at the later time in the morning, thus coupling patient's schedule.Certainly, any this type patient's adjustment must be arranged in the prescribed regimen scope of the broad that prescription medical science supplier limits.These modifications that are asked to can provide the additional information about the simpler rules of drug administration to trial person, perhaps can guide the non-compliance of the testing regulations of specific individuality is examined.
Can estimate that according to the present invention through touching or user-friendly graphical interfaces, the user can operate many prescription factors easily; And can typing those maybe be to the useful additional information of prescription medical science supplier; Degree of fatigue for example, hunger intensity, vibration imports medicine or the like.All these data collection points allow patient more successfully to take medicine, and more possibly comply with in the prescription rules.
Referring to lower part shown in Figure 10, the time that horizontal line is represented that patient ingests or otherwise taken medicine.Patient can show medicament reservoir and/or certain pill or other drug form to imaging device then; This imaging device is through user's text identification; Pill identification, or other suitable pharmaceutical recognition mechanisms confirm that medicine is correct and is the current prescription drug that to be ready taking.This series of steps is carried out when taking medicine as audit trail at every turn, also can be used as postmortem, thereby guarantees that patient correctly follows this scheme.
According to the present invention, patient obtains confirming to the compliance of the medicine of prescription management arrangement.According to the present invention, this affirmation possibly carried out in a variety of forms, and its method for optimizing possibly comprise gathers the actual video program of taking medicine of patient.In further preferable methods; This program that is used to confirm possibly comprise adopting face recognition program or other biological to measure identification confirms whether be that particular patient is being received treatment really; But the ability of facial or other the special characteristics that can blur the user can be provided also; Thereby protection user's identity when storing and using these images a kind ofly provides about the symposium of this clinical testing and the technology of situation about need not remedy to particular patient as the keeper.Action recognition, gesture identification or other are used to confirm the characteristic whether specific experimenter's action meets the predetermined action program, possibly be used to all guarantee that patient correctly takes prescription drug.
In addition, according to the present invention, thereby patient takes really or the video image of the medicine of ingesting can be taken and store and get off to obtain certain affirmation, rather than it took certain drugs to rely on patient simply.Consider the optional type of action or gesture identification, special embodiment according to the present invention, this video image can be gathered or store by suitable form.Can comprise: complete video; The biometric data point; The moving recording of article (these article for example patient or keeper with bangle etc.), use drawing or other human body mobile trackings technology that the stick figure is provided, perhaps gesture or other are confirmed the action recognition means of action etc.The user can be encouraged to use specific mobile process correctly to take medicine to confirm them according to rules, thereby has reduced the possibility of potential suitable mobile being considered to " correctly ".In fact, can provide various instruction images or other suitable trainings correctly to take medicine to the user to guarantee them.At last, according to the present invention, if can not write down the video that patient takes medicine, system of the present invention will identify this situation and require audio frequency really to select as second.If audio identification is also impossible, also can accept more insecure confirmation method, confirm such as patient's keyboard.If the confirmation method of higher confidence level all can not adopt in a period of time that continues, this system will preferably give the alarm to the medical expert, remedies with the inquiry reason and to this situation of taking that possibly make mistakes.
These steps of confirming that identity, affirmation medicine and affirmation are taken are all checked the compliance of examining the prescription rules 1035.This inspection is preferably carried out through computer system automatically, and this computer system can be compared real recording image and image desirable or expection, and perhaps other actions or the gesture identification through user recited above automatically performs.Technology as for face recognition and bottle or pill identification is techniques well known.Video about the compliance of prescription drug being taken process confirms that this process possibly comprise: various stick figures' comparative analysis, and the action recognition analysis, or whether other affirmation patients recited above have carried out the plan of suitable action.
Provide the ability of the automatic affirmation of the compliance that correct takes process to make these a large amount of images in the short time period, to be examined.Can not 100% under some possible situation confirm even lack compliance really and completely, thus prescreen take that ability that the situation of taking that video will obviously obey gets rid of reduced basically need be by a large amount of submissiveness situation of medical expert's inspection.Extra hand inspection to the instruction of compliance failure can be provided, thereby guarantee that when reduction needs the quantity of the image of hand inspection greatly all potential unsafe conditions are by suitably inspection.Therefore, this automatic system has realized multiple benefit, when having improved quality, has reduced the time of checking these images, has reduced the expense of these inspections, has improved patient's the right of privacy through crowd's quantity of these data of restriction inspection.
In another embodiment of the present invention, confirm that the imaging application of scheme compliance can further be used for checking bad reaction or other reactions of taking medicine thereby be used to action recognition.Therefore, except confirming the suitable compliance of rules simply, this action or gesture identification also can be confirmed the many different behavior that patient takes.Therefore, take medicine and can understand some specific reactions etc. in depth with behavior afterwards before.Therefore, according to the present invention, before taking medicine, action recognition can be confirmed user's current action.Any prompting of taking medicine subsequently possibly be based in part on the action of this affirmation.For instance; If the user is putting on overcoat, perhaps to confirm to leave residence or other facilities or the like, the medication alert before leaving will be sent; Even than wanting Zao usually; If perhaps medicine is of portable form, the user can be alerted and carry medicine, and takes medicine through the reminder announced on the mobile device subsequently.Further be exemplified as,, will be emitted in the prompting of taking medicine before having a meal if the user cooks.Other situations also are possible, thereby the permission system has more reaction to take medicine suitably to guarantee patient.In addition, according to the present invention, patient's various letters of consent will be by prompting and record.Patient possibly seek advice from the further accessory problem about these letters of consent, thereby guarantees that patient has all information of the informed consent made decision, and guarantees that the medicine supplier has the suitable evidence of these agreements.
Similarly, take medicine behavior afterwards and also can understand the patient reaction in depth.Faint, fall, handicapped, facial expression, the performance of digestive discomfort or the like all can be counted the bad reaction of specific medication scheme, thereby allow after patient's dosage instructed with prescription adjust.If bad reaction is serious, system will provide drug test timely and solve this problem with getting in touch of medical expert.In addition, can directly be connected with pharmacy or medical science supplier's system or cooperation each other according to system of the present invention, thereby make this DM, the suggestion of scheme change or the like is transmitted to these experts automatically.Through these links, the medicine rearrangement, DM, drug replacement etc. can be provided automatically.In addition, because pharmacists or medical science ISP can obtain patient information, drug information and prescription information obtain extra prescription and will become more easy.
Adopting these robotizations, perhaps after robotization and the technology that manually combines, carrying out compliances 1040 and confirm, allowing health care supplier or other medical experts inspection and examine the result of automatic comparison, the perhaps direct operation program of being gathered of checking; And needed identity, the variation of medicine or application process possibly require the keeper that this situation is checked, if necessary really will intervening.When being in an emergency; This inspection can be required to carry out immediately when perhaps patient wants help through gesture or other action signals; Perhaps this inspection possibly be more not urgent, just possibly require to carry out E-communication with keeper or similar personnel and obtain to advise or other.In addition; This compliance inspection can be given patient and stores according to the time; Thereby allow to confirm various medicine trend; For example, if patient misses medicine in the same time in each week, perhaps indicate certain specific medical care and health personnel who assists patient to give the drug dose that makes mistake aperiodically.Therefore, except allowing the problem in the drug administration notified timely, also formed the audit trail of the behavior that is used to follow the tracks of a plurality of health care suppliers.This audit trail makes that clinical trial management person or other medical experts can be immediately; Perhaps after, confirm whether particular patient or patient group are followed scheme and arrived that to a certain degree make can be with their result as the part of research to the inspection of complete pharmaceutical admixtures.In addition, the compliance level can be understood the use difficulty or ease of specified scheme in depth, and whether the instruction that offers patient has considered the compliance to the prescription drug scheme sufficiently.
Therefore; Shown in figure 10; According to the invention provides a kind of method and system, wherein patient's compliance to the prescription drug scheme in the clinical testing sight can obtain inspection, is specially adapted to a specific example is perhaps confirmed patient's behavior along with the time any change.Therefore all aspects of this compliance are all preferably visually monitored, and do not rely on the affirmation of patient to drug administration, and person in charge's factor of patient is disallowable, thereby the certain process that can study in drug administration is checked really.Therefore trial person can make patient continue their prescribed regimen; Thereby reduce the full payment relevant, thereby comply with when prescribed regimen reduces accuracy of experimental results with repeatability patient is gone into the crowd to get rid of from test when patient can not keep with clinical testing.Through the management to a plurality of clinical testings, patient's interaction is eased, and respectively any similarity between the test also can obtain confirming, thereby improves the quality of nursing basically, and guarantees a large amount of consistance of testing.
Next with reference to Figure 11, the more accurately description that data, medical record and prescribed regimen are entered the mouth will be described in this.Shown in figure 11, clinical trial management person 1102 imports system of the present invention with information, particularly imports the information about pharmaceutical admixtures, dosage, instruction group or the like.Patient 1106 can also import the information relevant with patient.Trial person 1102 can further import or change patient information, preclinical medicine data and the actual every other medical information that is included in the database.Patient 1106 possibly only limit to provide personal information, and maybe other relevant information, such as the use of OTC, and potable spirit, recent symptom, to the reaction of the use of specific prescription drug, or the like.Certainly, any this information can be from database of having logined in advance or the region of data storage automatic input system that have earlier.And, if information specific is omitted by patient, perhaps can not obtain, might require this information of standard, perhaps patient is got rid of from clinical testing.In addition, the affirmation of the normal processes of information collector failure can be used to confirm, makes the inadequate patient of information gathering before getting into clinical testing, add and trains or be excluded.
The information that obtains from each user of system combines in obtainable place, and forms clinical testing medicine inlet 1110.Particularly, for system is put in order, the inventory of information is provided at first preferably according to the present invention; If the user is not patient, possibly comprises patient name and user's name, and will be used to provide various warnings; The information of patient's mail of reminding such as writing out a prescription, doctor or paramedic are used for the contact details of emergency interconnection, for the email address of various high capacity or non-emergent interchange; And the mobile phone or the landline telephone that are used for patient link, or the like.To trial person 1102 provide further notice make the keeper can monitor patients to medicine use and to compliance suggestion or that prescription drug is taken.In addition, according to the present invention, patient and other peoples' relevant with system facial image all is stored; Perhaps other biological measures identifier; Fingerprint recognition for example, retina identification, voice recognition; The various RFID labels that provide, or the like all can be combined more traditional passwords and user's name or the like mode use.Certainly, if patient is the secondary treatment, these information can extract from the available data storehouse that stores previous prescription.
Next, the user, for example doctor 1102 or pharmacists 1104 or nurse can provide a specific new or old prescription drug to the user according to this clinical testing.The user can get into outside drug data base 1115; Thereby obtain information about these medicines; Comprising medicine name, is the suggestion of the suitable prescribed dose on basis with the patient information, and the specific translation that will take medicine; To the directions for use that patient provides, these instructions in case of necessity can be revised or replenish by trial person.These directions for uses preferably include the detailed explanation of taking, and comprise the time, patient condition (ante cibum or after meal just, after getting up, before the sleep, or the like), clear and definite method of application, and other are for the useful explanation of user.Thereby these explanations also possibly comprise the specific detail of describing medicine and take the action that the video program of process suitably indicates patient to carry out.These explanations also possibly comprise selectable explanation translation, if the user is unclear to specific a series of instructions, thereby also possibly provide optional a series of explanations to help to improve the compliance of patient to this prescribed regimen to patient.
After medicine is selected, thereby the medical history taking 1117 that preferably gets into patient provides additional medicine and patient information to trial person, and these information possibly comprise; Thereby other prescriptions of patient are confirmed the spinoff (if other prescriptions are implemented according to the present invention, the native system known should be write out a prescription so) of medicine, the patient's that OTC uses performance; Allergic symptom; Activity level, the disease in past and process, and any maybe the information relevant with drug prescription.
When with all information for after the user input, after accumulating about the information of medicine and patients database, system carries out self-verifying in step 1120 pair various drug responses.Thereby make trial person notice dangerous interaction stop this prescription entering system, and this clinical testing of prevention particular patient participation.Thereby trial person also possibly notice other interaction warning patient and these situations can occur.Possibly comprise, for example, two kinds of medicines are taken together possibly cause the warning of having a stomachache, thereby patient is taken with evening respectively in the morning.These interactional inspections cause will a series of explanations being provided to the user except more conventional medicine explanation.At last, trial person possibly check these instructions and replenish according to demand.It should be noted that; Can estimate according to the present invention; The various instructions that provide to the user possibly comprise and hot link supplemental audio and visual information; These information possibly be provided for patient and further improve their compliance to specific prescription rules, and the various information about the specific medication of being taken perhaps possibly are provided, and are said below as further.These instructions can indicate the method that the user takes a kind of or more kinds of medicines, thus request certain gestures and other use in taking.
At last, after all interactions and inspection of instruction process and authentication, prescription information stores in step 1125.The storage of this prescription makes patient and other system user can obtain alarm, help information, or the like.In addition, can also prescription be sent to pharmacy or other drug supplying unit, make the user can select medicine easily by the way and perhaps medicine is handed to patient.
Next with reference to Figure 12, user's according to the method for the invention enforcement will be described below.When to the time of accepting or taking medicine, patient and any other user who needs can be provided one and notify 1210 according to what Notify Address got into aforesaid system.Therefore, if be in, so only patient can receive notice.If the family healthcare supplier, these suppliers possibly also can receive independently affirmation separately.If hospital or other inpatient's care institutions vibrations, each medical science ISP can receive this notice equally.After giving notice, perhaps do not give notice, system starts 1215.According to such system start-up, one or more users are preferably by system identification.Therefore, in step 1220, carry out user's recognizer.In a preferred embodiment, the image static or video of this user's face is gathered, and adopts facial recognition techniques to confirm user's identity.This collection can be adopted fixed cameras, mobile camera, mobile communication equipment, mobile phone for example, or any other suitable video or image modalities.Optional recognition technology, such as, except modal cipher inquiry, also can adopt retina, fingerprint, sound or other biological measurement.When image is used as about compliance but not during the general report of individual patient reaction, any other suitable recognition technology all may be utilized, any unique individual indications is fallen in covering simultaneously, as stated.
In step 1225, determine whether that all essential users are all by identification and authentication.The nurse; Doctor or other paramedives distribute under the situation of medicine, thereby make preferably whether patient and paramedic have followed appropriate processes through the further affirmation of the identification of system, and make system log (SYSLOG) make the personnel of medicament; Thereby follow the tracks of; For example, if anyone unsuitable medicine that used, in final audit trail with fairly obvious.After the step 1225, if all users are not recognized that all step 1220 is got back in the control path, through any other user of system identification.
In case all users through identification, control path to step 1227, this moment, prescribed regimen was according to the rules recognized the medicine that will take.Therefore, the user is pointed out and is used image static or video, text identification image; Or the method for other identification medicine is gathered medicine bottle or other containers; Pill, or the medicine of other formulations can also be confirmed suitable quantity; Dosage, and any potential essential or dangerous drug regimen.As stated, if video is confirmed can not carry out for a certain reason, the user can be provided indications audio frequency or other drug and other information that need by system prompt.Then, this image, the affirmation information of video program or other receptions will compare with the relevant image of prescription, as shown in Figure 11.If it is wrong that medicine is determined, will provide medicine incorrect warning to the user.The user can be selected another medicine is carried out to picture then by prompting.
Alternatively, the present invention estimates that the user can show the image collection device with multiple medicine, and making device that which kind of provide is the suggestion of correct medicine.Therefore, the user can use this video imaging apparatus scanning medical cupboard, and making system that which kind of indicate is correct medicine.Quite important when the order of the medicine of ingesting, perhaps take similar medicine and when distinguishing each other medicine and having difficulties, it is very useful that this point is proved to be as two people.In case correct medicine is identified, control path to step 1230.
In step 1230, to patient, current paramedic user prompt and other instructions are provided, about the instruction of how to take medicine according to the above-mentioned prescription guide of confirming in the clinical testing under consideration.This instruction makes the user can receive further information or instruction through seek extra help to system in case of necessity.Particularly requiring under the situation of detailed planninng, can estimate that the user possibly obtain the sample and the instruction of video.In addition, according to the present invention, for the process of taking of complicacy; Possibly adopt traditional video conference, VOIP meeting, traditional teleconference; Perhaps any other suitable communication system and expert carry out the two-way video meeting, make paramedic or patient can receive the live telecast instruction about taking.Thereby these instructions and prompting can provide success or the failure of confirming the specific instruction group by clinical trial management person.Therefore; DO need not tested in clinical testing, thereby the instruction group also need test to confirm which kind of is best for everyone, or for demography group or the like; Or for final user when medicine is provided to the public, thereby realize the public's better compliance.Along with the growth of clinical testing quantity, the place of these tests becomes and internationalizes more, will become more important through a plurality of clinical trial management persons of system management according to the present invention.
When following these command prompts, the actual act of taking is preferably gathered in step 1235 with video program.Therefore this is taken and preferably includes one or more discernible gestures that instruction as described above is advised.Therefore, patient or keeper possibly be provided one or more images or the program for application or instructions of taking, thereby ensuing these programs are used for confirming the compliance to specific prescribed regimen.In addition, the long-time or keeper that can be confirmed as feasible test participant that pauses further understands the zone of bringing problem in depth.The video program of this collection can use in many ways according to the present invention.At first, real-time inspection is carried out in the action of taking medicine, and compare with video program desirable or expectation.If confirm that medicine is taken with the mode of mistake, perhaps take with the mode that patient is harmful to, will cut out immediately give a warning immediately suggestion paramedic or patient of step 1240.In addition, under some extreme case, can notify doctor or other paramedives, perhaps under extremely dangerous situation, ambulance or other responding agencies possibly be scheduled for this place nursing timely is provided.Notice also possibly be provided for clinical trial management person, warns its one or more patients that there is the compliance problem in these rules.If this problem is proved to be independently, optional instruction or individual help all can remedy this state, thereby make patient to test significant data are provided.If generally lack compliance, clinical trial management person possibly change instruction for all participants, perhaps even ask all participants to return to accept further on-the-spot instruction.Under any one situation,, cause the research failure to be avoided owing to lack the rules compliance, so the expense of clinical testing reduce greatly because the participant all can keep under study for action.Do not comprise the image of identity characteristic etc. through employing, can be provided for the keeper, make this report accurately show privacy and the secret of having protected patient when medicine is how to take based on this report that generally lacks compliance.If can not obtain videograph, also can adopt aforesaid other confirmation methods, as the videograph program, confirm automatically.
If do not require urgent nursing or warning, control path to step 1245 at this moment, is more formally gathered video image, and is used for analyzing various other not dangerous situations.Image can carry out the part to be gathered and stores, and in batch processed, serves as central server, and perhaps image also can be gathered and send to remote server and be used for analyzing timely and storing.This transmission can connect at whole known network, wireless connections are perhaps carried out in other private communication systems.This analysis can consider to propose to improve to the paramedic accuracy of dosage, reduces medication pain, or the like suggestion.Before medicine was distributed to the public, these suggestions can be converted into various instructions or training program.In addition, participate in patients current or a plurality of clinical testings and/or paramedic in a large number and all can obtain this video program, thereby the validity of various series of instructions etc. is tested and checked, if meet with identical problem then change always.If such research does not have the present invention almost can not carry out, because in the clinical protocol of any kind, what individuality can be careful when taking medicine is many, therefore can not make mistakes.When they returned in to the home or get back in the life clocklike, Here it is proposed the opportunity of compliance kimonos with matters.According to the present invention, can analyze reaction to instruction, also can remedy owing to obscuring or be difficult to follow the compliance deficiency that instruction causes, better or more available instruction is provided, thus the compliance of improvement project.Do not have the present invention, clinical trial management person possibly just not know these matters.Because in a single day just can be notified appears in existence of the present invention, these matters, thereby guarantee the integrality of clinical testing.
In any case, analyze through these, can point out it possibly is problematic instruction area in step 1250 generation warning for any warning or the suggestion of instruction.These video programs are if needing also can store in step 1255 is used for long-term analysis, and terminal processes.In addition, maintain in the clinical testing in order to encourage patient, the notice that lacks compliance can be used to change the remuneration that patient receives in clinical testing.Therefore, make patient obtain higher remuneration, in scheme bigger power is provided for the patient compliance to the compliance of scheme.
The trend of participating in the patient of this clinical testing can obtain monitoring; For example patient's blood pressure or other measurable numerical value; And the relation between these measured quantities and the drug administration also can be observed; Make patient can obtain the pharmaceutical admixtures of customization of individual character potentially, can make amendment to the dosage or the frequency of taking based on individual reaction to specific prescribed regimen.In addition, characteristic of the present invention as stated makes user's the movable record of interaction and user, thereby and bad reaction or the like all can be dissolved into and provide further information confirming optional instruction group in the system, the modification of medicine, or the like.
Further estimate that this clinical trial management person is provided keeper's instrument panel to realize the inspection that gathers to all patients of participating in one or more clinical testings.The details of the example embodiment of this instrument panel will be described following, referring to Figure 13-15.Shown in figure 13, the page that gathers of instrument panel is depicted as 1300.Each different clinical test estimates to have one or more pages (consider participant's quantity, it possibly be necessary that the page exceeds one page) that gather for some specific clinical testing.Each summary page face comprises the designator 1310 of participating in all participants of particular clinical trial to each.Designator among Figure 13 is depicted as people of each icon indication.The also replaceable one-tenth of these icons gathers identifying information etc., perhaps any other desirable designator, for example the demography designator (that is, and age group, sex, medical condition, idiosyncrasy, or the like).Also has the designator legend that comprises the information that goes for any one or a plurality of designator 1310 on the instrument panel 1300.In a certain preferred embodiment of the present invention; This designator legend comprises indicator mark, this mark indication: seeked advice from problem or required for one and report out lower submissiveness to the special test participant that some instruction or other aspects of clinical testing carried out setting forth.As shown in the figure, each indicator mark can be applied to specific designator 1310 and carry out mark with sign.Therefore, as shown in Figure 13, designator 1312 is marked as bad submissiveness, and designator 1314 is marked as counseling problem.Therefore, by this way, make clinical trial management person can scan the patient condition in the clinical testing.Clinical trial management person can confirm most of submissiveness problems easily through browsing instrument panel, has the designator 1310 that is labeled as bad submissiveness by indicator mark on this instrument panel.Similarly, if gather a large amount of problem or the elaboration requirements of demonstration on the page, the problem of this instruction possibly be fairly obvious so.Certainly, also indicator mark can be provided for a large amount of other problemses.The statistical study of clinical testing colony also can be provided, thereby allows clinical trial management person to confirm the integral body of this clinical testing colony or the compliance ratio and other indexs of segmentation.This mark is preferably color indicator, comprises that also any other suitable designator makes clinical trial management person confirm state.
Instrument panel 1300 further preferably includes the convergent-divergent designator; Thereby thereby the patient who allows clinical trial management person to narrow down to each patient or lesser amt watches their comprehensive submissiveness statistics; Perhaps watch the video program of record; To additional information, or the request of stored any other information of the audit trail that is used for patient according to the present invention.Therefore, if the convergent-divergent designator narrows down to minimum, clinical trial management person can observe the designator 1310 of maximum number on the instrument panel.The moderate convergent-divergent preferably provides window as shown in Figure 8 to clinical trial management person.As shown in the figure, designator 1312 comprises the information adjacent with designator.In the situation of being showed, also show the title of indicator mark.This point is useful when a large amount of indicator mark are provided.Alternatively, the text can comprise the most critical part of information, perhaps the information picked out of user.This zoom feature also possibly allow clinical trial management person to dwindle through similar population demographic information, thereby watches representative has the clinical testing participant of similar characteristics with one or more forms designator 1310.
In addition, can estimate that clinical trial management person can use gathers instrument panel, with any desirable convergent-divergent degree the subclass that is included in the designator in the clinical testing is selected, moves, is indicated or operation.Therefore, one or more participants can be assigned to different colonies and group as required receiving different instructions, and dosage perhaps carries out any other sign of drug administration to selected participation group.The participant also can be considered to the useful mode of clinical trial management person is divided into groups according to prescription medical science supplier, clinic, medical science group, insurance company or any other.Through grouping, might confirm it whether is the bad compliance that any specific clinic, doctor or the like cause this group to these groups.Therefore, relevant with particular group bad compliance also can be handled through the additional training to clinic or doctor.The participant can be added in the research of special test or other epidemiological studies etc., or from wherein rejecting, if desired, perhaps carries out other operations.Dividing into groups also can be automatically, for example with all patients through the age, sex, perhaps other Demographics are divided into groups, thereby useful fast view are provided for clinical trial management person.
Further zoom to single designator, make clinical trial management person watch the more designator of peanut.Along with the decline of the quantity of designator, the quantity of information of each designator that clinical trial management person obtained is many more.Therefore, clinical trial management person can zoom to each possible degree as shown in Figure 15.Shown in figure 15, first zoom degree shows the extent of information of Figure 14, and this moment, a large amount of designators 1310 remained visible.A more detailed zoom degree preferably illustrates.Identical bad submissiveness designator, but further showing this bad submissiveness relates to the short supply of medicine schedule, particularly medicine, thus the more complete compliance inspection to the clinical testing participant is provided.(or suggestion) training video because that the participant does not also check is necessary, and the 5th step in the affirmation scheme that limits have any problem, this information further provides the information by the participant's of this indicator representing bad submissiveness.At last; In order to understand more information about bad submissiveness; This designator is carried out further convergent-divergent; This participant is shown only has only 7% behavior to confirm through video, 10% confirms through sound, and remaining 83% confirms (this gui interface depend on patient therefore be considered to be not so good as other two kinds of method that kind credible) through gui interface.In addition, this participant seeked advice from a specific problem.According to this specific convergent-divergent degree, estimate that clinical trial management person may be directly connected to the information that video, audio frequency or the GUI of storage provide.Preferably, clinical trial management person is provided a time shaft, and this time shaft indicates various, video, audio frequency and/or GUI input when be stored.This clinical trial management person can observe the more useful picture of compliance program, and the program that can pick out any one storage then is used for inspection.This keeper can also answer query, perhaps problem is pass on to the doctor or the similar personnel that are suitable for answering this problem.This clinical trial management person can also select to change the instruction that is provided for one or more patients according to the record of the compliance after carrying out first series of instructions.This zoom degree can also provide to the participant and allow to exchange with particular participant, and the method for the additional training of suggestion, instruction or help, and the link of ordering or provide the program of medication.Can also check the special instruction to patient that patient provides, parameter is selected, perhaps comment or the like.At last, clinical trial management person can check the prescription information that is about to send, and comprises the number of times of taking the prescription or being applicable to one or more patients' other drug.
Therefore through such instrument panel, clinical trial management person can receive the notice of any problematic failure of intervening about patient's warning, or directly contact, and change scheme or instruction are perhaps recalled patient and retrained.As stated; Need not wait for that patient returns and report bad compliance; Perhaps worse situation; Make patient's data become the part of the data of clinical effectiveness, even have bad compliance, this clinical trial management person can use instrument panel of the present invention to guarantee that bad submissiveness is by EARLY RECOGNITION and processing.In addition, emergency can indicate to clinical trial management person immediately.
This instrument panel preferably has the patient's except above-mentioned notification feature the characteristics of management.Therefore, this clinical trial management person can manage individual participant through functional click and/or drag operation, colony's subclass, and perhaps whole colony can propagate information to these groups as required, comprises transmit video, text or sound instruction.The also preferred participant of prompting of this clinical trial management person doctor on the horizon preengages, and about the meeting of clinical testing, this notice can also be provided to patient's prescriber.In case notify participant's medicine to use up, perhaps only through the actual medicine of taking of track participant, for the participant provides extra medicine or goods and materials.Therefore, without any need for conjecture.This keeper can check as required further that thereby patient's medical record further improves the submissiveness of process of the test.
This instrument panel also preferably provides the medical expert's relevant with one or more clinical testing participants inlet.This test provides under all prescription doctor or other medical supervision persons' the situation to those patients that possibly want help; This characteristic possibly be unessential; But, can provide information can be proved to be very valuable to these doctors with exchanging each other when a plurality of prescription doctors have all participated in test.This contact can relevant with each patient identifier symbol icon link or connect realization through what provided on the instrument panel.Therefore, this clinical trial management person can check video or other compliance marks with such prescriber, and any complication that patient possibly occur in process of the test is carried out long-range classification, perhaps requires to write out a prescription replacing, or the like.In addition, this clinical trial management person can take medicine in the treatment of after this examining the medical expert and according to prescription clinical testing process.Through this audit, this keeper can confirm the relevant matters of action with the specific personnel that take.
User's instrument panel can be provided as allowing participant's input information, and the submissiveness information of for example above-mentioned GUI input can also be putd question to, and checks additional instruction, orders goods and materials or the like.The user can also check more specific prescribed regimen information, and when for example next medicine is predetermined takes, or provides a calendar to be used for the predetermined time period in the future to realize prospective project.Through such user's instrument panel, the user can check the information specific relevant with their treatment, but preferred these information are not enough to influence their participation to test.If in use, the participant can also check according to the present invention whether they have accomplished and can cause the various compliance degree paid.In addition, the user can be provided definite method that a kind of data transmit degree, comprises the identity information that the keeper as various degree provides.Therefore, when all information after clinical trial management person provides, may more limited identifying information be provided to other researchists or similar personnel.This participant can potentially be used by notice, select to get into or selects to withdraw from a series of selections and realize disclosing in various degree.The user can be provided privacy designator is set, and indicates the obtaining degree of information recorded and additional identifying information thereof.
Therefore, this instrument panel confirms that with exercisable clinical testing the system of program and above-mentioned light use combines, and has increased validity and has allowed this clinical testing is better controlled.Following the difficulty of rules can almost confirm in real time.The change of test can easily realize and pass on to test participant and their prescription doctor.New training module, thus comprising that video, text or other instructions can provide in test improves compliance.Inventory management is more easy, and all test participants are guaranteed to have the suitable consumption of medicine and other goods and materials.In addition, keep omnidistance audit to follow the trail of and visited any particular patient, patient group, or the information of one or more clinical testings.But this instrument panel is not limited in clinical testing and uses.This system also can be by a medical science supplier, doctor's group or network, insurance company, government organs, nursing home, poorhouse, family health care supplier or the like; Perhaps other groups are used, thereby follow the tracks of a large amount of patients and relevant residential care personnel, doctor or other drug keeper.Under this situation; Watching, dividing into groups and retrieve the better control that allows patient the important information of given patient; Thereby reduced patient and continued to take wrong medicine; Perhaps take the possibility of these medicines by error, thereby reduced bad reaction or dead possibility that specific medication causes successively.
Comprise imaging technique and hardware according to system provided by the present invention; Communication hardware; Comprise storer, be used for the telecommunication of remote storage and analysis, enough realize the computer system of database of patient information and the drug information of aforesaid method through network or other communication networks.All communications are all to have carried out encrypting or other protections in this locality or the long-range a plurality of storage unit time transmitting or being stored in, to meet the desired any regulation of security matters and storage and maintenance medical science and patient medical healthcare information.
Therefore, allow the automatic affirmation of the compliance of the rule of management of medicine in the clinical testing environment, and be provided for confirming and studying the exact method of the instructions of taking of these prescription drugs according to method and system provided by the present invention.
At first, show remote information harvester 1600 referring to Figure 16.This device is applicable to the collection and the processing of the information of carrying out, so that implement according to aforesaid application and be integrated in this system and method by reference.This information collecting device 1600 is preferably network or other communication systems through a communication system 1700, is connected with teledata and calculating storaging unit 1800.Through communication system 1700, be sent to teledata and calculating storaging unit 1800 by device 1600 information of being gathered, and analytical information or other instructions can be sent to device 1600 from teledata and calculating storaging unit 1800.Further estimate, compare with a harvester institute region covered, but the bigger zone of a plurality of this information collecting device 1600 cooperations monitoring.Therefore; This device can be recognized the existence of other devices; And one through all information are sent in the device 1600 turns round; Perhaps these devices can be separately independently with remote information and calculating storaging unit communication, this calculating storaging unit is applicable to the various information that come from multiple arrangement 1600 of integrating.
Next with reference to Figure 17, show the detailed maps of the remote information harvester 1600 and the preferred embodiment of teledata and calculating storaging unit 1800.Shown in figure 17, device 1600 comprises the information acquisition equipment 1610 of gathering video and voice data as required.Motion detector 1615 or other suitable trigger apparatus can be provided with collecting device 1610 and interrelate, thereby realize the startup and the completion of data acquisition.Information acquisition equipment 1610 can comprise the vision data collecting device, maybe can be provided one ultrared, night vision, or other suitable message collecting devices.Storage unit 1620 further is provided for the information of storage of collected, and processor 1630 is provided for these collections of control and storage, and other functions relevant with the operation of remote information harvester 1600.Analysis module 1635 is the part that the analysis of any information of gathering with execution remote information harvester 1600 is provided according to processor 1630.Device 1600 further is provided as and has a display 1640, and data transmission is used for display message with receiving system 1650 and 1660, and and teledata and calculating storaging unit 1800 connections.Teledata and calculating storaging unit 1800 comprise system management function 1830, and transmission and receiving system 1850 and 1860 are used for and install 1600 being connected.This system management function comprises, at least in part, described in many concentrated functions such as above-mentioned ongoing three patent application cases, and is integrated in this by reference in advance.Transmission and receiving system 1850 and 1860 may further include various GPS modules; Make the position of equipment to be determined at any time; And can further message be sent to one or more independent device; Be broadcast to all devices in the special test, or be used to the management of specific prescribed regimen, can obtain the broadcasting of device to all.
According to the present invention, device 1600 is parts of improving the system of medical science scheme compliance in clinical testing and other medical supervisions in the works.Make the keeper with the tangible affirmation of carrying out compliance with mode accurately or lacking compliance according to the use of the device 1600 of native system, and carry out early intervention during the course and guarantee that the patient who participates in this clinical experimental study correctly takes medicine.Device 1600 of the present invention is applicable to patient receives and offers patient from the instruction of teledata and calculating storaging unit 1800 and with these instructions about the use of prescription drug.These instructions possibly comprise: written, audio frequency or instruction that audio frequency is visible is used to instruct the user to comply with in the prescription rules.Device 1600 further provides patient affirmation to the compliance of prescription rules Xiang doctor or other ISPs, and statistics and the micro-analysis rate of complying with are taken to guarantee suitable clinical testing.
Next with reference to Figure 18, show the data stream overview of the operation of device 1600.According to the present invention; Information about the particular medication that becomes the clinical testing object is provided by database 1805; Existing industry drug information database 1810 is applied to the visit prescription, interacts, and uses; With prescription and OTC about many suggestions, and possible interactional other available informations of they and clinical testing medicine.In addition, use patient's medical record 1815, and as as described in following the carrying out with medical record and industry medical information and medical expert's prescription professional knowledge combine with the affirmation patient be so the good person of a clinical testing.In case confirm, the medical science scheme that meets the clinical testing requirement is left and in step 1820 input system of the present invention.In case be transfused to system, specific prescribed regimen forms a series of user instructions 1825.According to clinical testing, these instructions can change confirming best a series of instructions according to different user, or the factor of the instruction that can possibly require to provide dissimilar according to population distribution, experience or other changes.Further can estimate according to the present invention; Many clinical testings can be managed according to the present invention by the keeper; Make the present invention estimate to form a clinical trial management system, this system allows to carry out single point of management with specific all relevant clinical testings such as keeper.
These user instructions possibly comprise the general remark to current test about the specific medication experimenter; The method of ingesting; Spinoff warning, to common material or medicine, or other are left the worry of the drug response between the medicine by this system or another health care provider.Can estimate that according to the present invention these user instructions can interact, allow the user to browse additional information as required about these instructions or prescription.These instructions possibly comprise by device 1600 display 1640 to the user provide written, sound, perhaps video instructions.In addition; Expectation is according to the present invention; Place, arbitrfary point in the instruction group, for example, when patient passes through the problem with message input device 1600 inquiry particular types; When perhaps require accepting the additional information about the particular aspects of medicine or prescribed regimen; This device 1600 can offer assistance and get in touch with the delegation of health care provider with 1660 through transmitting with receiving system 1650, thereby for patient provides individual's help of extra necessity, if definite this medical expert's intervention is desirable to patient.Therefore, patient can suitably be taken medicine by auxiliary, thereby avoids finding multiple mistake.In fact, in more traditional situations, only possibly and feed back to the doctor there after accomplishing prescribed regimen and could find that medicine is taken by error afterwards according to predetermined clinical testing arrangement.According to the present invention, can be employed to stop about the early intervention of these situations owing to take the possible adverse consequences that medicine brings inadequately, thereby guaranteeing that particular patient is in this research process also provides accurate data for this research.
Can estimate that according to the present invention through touching or user-friendly graphical interfaces, the user can operate many prescription factors easily; And can typing those maybe be to the useful additional information of prescription medical science supplier; Degree of fatigue for example, hunger intensity, vibration imports medicine or the like.All these data collection points allow patient more successfully to take medicine, and more possibly comply with in the prescription rules
Referring to lower part shown in Figure 180, the time that horizontal line is represented that patient ingests or otherwise taken medicine.Patient can show medicament reservoir and/or certain pill or other drug form to the image modalities 1610 of device 1600 in step 1830, and this device can be carried out this locality through processor 1630 and relevant analysis module 1635 and handle and analyze.This device 1600 is through text identification, and pill is discerned, or making of other suitable pharmaceutical recognition mechanisms is used for confirming that medicine is correct and is the current prescription drug that to be ready taking.This series of steps is carried out when taking medicine as audit trail at every turn, also can be used as postmortem, thereby guarantees that patient correctly follows this scheme.
In addition,, can adopt device 1600 to take that patients take really or the video image of the medicine of ingesting and it is stored in the storer 1620, thereby obtain certain affirmation, rather than rely on patient simply and took certain drugs according to the present invention.Consider the optional type of action or gesture identification, special embodiment according to the present invention, this video image can be gathered or store by suitable form.Can comprise: complete video; The biometric data point; The moving recording of article (these article for example patient or keeper with bangle etc.), use drawing or other human body mobile trackings technology that the stick figure is provided, perhaps gesture or other are confirmed the action recognition means of action etc.The user can be encouraged to use specific mobile process correctly to take medicine to confirm them according to rules, thereby has reduced the possibility of potential suitable mobile being considered to " correctly ".In fact, can provide various instruction images or other suitable trainings correctly to take medicine to the user to guarantee them.At last, according to the present invention, if can not write down the video that patient takes medicine, system of the present invention will identify this situation and require audio frequency really to select as second.If audio identification is also impossible, also can accept more insecure confirmation method, confirm such as patient's keyboard.If the confirmation method of higher confidence level all can not adopt in a period of time that continues, this system will preferably give the alarm to the medical expert, remedies with the inquiry reason and to this situation of taking that possibly make mistakes.
These affirmation identity, medicine and the step of taking are all checked the compliance of examining the prescription rules 1835.This inspection is preferably carried out through processor 1630 and analysis element 1635 automatically; This processor 1630 can be compared real recording image and image desirable or expection with analysis element 1635, and perhaps other actions or the gesture identification through user recited above automatically performs.Technology as for face recognition and bottle or pill identification is techniques well known.Video about the compliance of prescription drug being taken process confirms that this process possibly comprise: various stick figures' comparative analysis, and the action recognition analysis,, or whether other affirmation patients recited above have carried out the plan of suitable action.
The ability of automatic affirmation that device 1600 correct that provided are taken the compliance of process makes these a large amount of images to be examined apace in the very first time, to confirm whether need pay close attention to immediately.Be described below, make a large amount of images in the short period section, be examined in teledata and the inspection of calculating on the storage element 1800.Can not 100% under some possible situation confirm even lack compliance really and completely, thus prescreen take that ability that the situation of taking that video will obviously obey gets rid of reduced basically need be by a large amount of submissiveness situation of medical expert's inspection.Extra hand inspection to the instruction of compliance failure can be provided, thereby guarantee that when reduction needs the quantity of the image of hand inspection greatly all potential unsafe conditions are by suitably inspection.Therefore, this automatic system has realized multiple benefit, when having improved quality, has reduced the time of checking these images, has reduced the expense of these inspections, has improved patient's the right of privacy through crowd's quantity of these data of restriction inspection.
In another embodiment of the present invention, confirm that the imaging application of scheme compliance can further be used for checking bad reaction or other reactions of taking medicine thereby be used to action recognition.Therefore, except on device 1600, confirming the suitable compliance of scheme simply, this action or posture are confirmed to confirm the many different behavior that patient takes.Therefore, take medicine and can understand some specific reactions etc. in depth with behavior afterwards before.Therefore, according to the present invention, before taking medicine, action recognition can be confirmed user's current action.Any prompting of taking medicine subsequently possibly be based in part on the action of this affirmation.For instance; If the user is putting on overcoat, perhaps to confirm to leave residence or other facilities or the like, the medication alert before leaving will be sent; Even than wanting Zao usually; If perhaps medicine is of portable form, the user can be alerted and carry medicine, and takes medicine through the reminder announced on the mobile device subsequently.Further be exemplified as,, will be emitted in the prompting of taking medicine before having a meal if the user cooks.Other situations also are possible, thereby the permission system has more reaction to take medicine suitably to guarantee patient.In addition, according to the present invention, patient's various letters of consent will be by prompting and record.Patient possibly seek advice from the further accessory problem about these letters of consent, thereby guarantees that patient has all information of the informed consent made decision, and guarantees that the medicine supplier has the suitable evidence of these agreements.
Similarly, take medicine behavior afterwards and also can understand the patient reaction in depth.Faint, fall, handicapped, facial expression, the performance of digestive discomfort or the like all can be counted the bad reaction of specific medication scheme, thereby allow after patient's dosage instructed with prescription adjust.If bad reaction is serious, system will provide drug test timely and solve this problem with getting in touch of medical expert.In addition, can directly be connected with pharmacy or medical science supplier's system or cooperation each other according to system of the present invention, thereby make this DM, the suggestion of scheme change or the like is transmitted to these experts automatically.Through these links, the medicine rearrangement, DM, drug replacement etc. can be provided automatically.In addition, because pharmacists or medical science ISP can obtain patient information, drug information and prescription information obtain extra prescription and will become more easy
Adopting these robotizations, perhaps after robotization and the technology that manually combines, carrying out compliances 1840 and confirm, allowing health care supplier or other medical experts inspection and examine the result of automatic comparison, the perhaps direct operation program of being gathered of checking; And needed identity, the variation of medicine or application process possibly require the keeper that this situation is checked, if necessary really will intervening.When being in an emergency; This inspection can be required to carry out immediately when perhaps patient wants help through gesture or other action signals; Perhaps this inspection possibly be more not urgent, just possibly require to carry out E-communication with keeper or similar personnel and obtain to advise or other.In addition; This compliance inspection can be given patient and stores according to the time; Thereby allow to confirm various medicine trend; For example, if patient misses medicine in the same time in each week, perhaps indicate certain specific medical care and health personnel who assists patient to give the drug dose that makes mistake aperiodically.Therefore, except allowing the problem in the drug administration notified timely, also formed the audit trail of the behavior that is used to follow the tracks of a plurality of health care suppliers.This audit trail makes that clinical trial management person or other medical experts can be immediately; Perhaps after, confirm whether particular patient or patient group are followed scheme and arrived that to a certain degree make can be with their result as the part of research to the inspection of complete pharmaceutical admixtures.In addition, the compliance level can be understood the use difficulty or ease of specified scheme in depth, and whether the instruction that offers patient has considered the compliance to the prescription drug scheme sufficiently.
Next with reference to Figure 19, user's according to the method for the invention enforcement will be described below.When to the time of accepting or taking medicine according to clinical trial protocol, patient can be provided by device 1600 with any other user who needs and notify 1910.Therefore, if be in, so only patient can receive notice.If the family healthcare supplier, these suppliers possibly also can receive independently affirmation separately.If hospital or other inpatient's care institutions vibrations, each medical science ISP can receive this notice equally.After giving notice, perhaps not give notice, optimum system choosing starts 1915.According to such system start-up, one or more users are preferably by system identification.Therefore, in step 1920, carry out user's recognizer.In a preferred embodiment, the image static or video of this user's face is gathered, and adopts facial recognition techniques to confirm user's identity at analysis module 1635.Optional recognition technology, such as, except modal cipher inquiry, also can adopt retina, fingerprint, sound or other biological measurement.When image is used as about compliance but not during the general report of individual patient reaction, any other suitable recognition technology all may be utilized, any unique individual indications is fallen in covering simultaneously, as stated.
In step 1925, determine whether that all essential users are all by identification and authentication.The nurse; Doctor or other paramedives distribute under the situation of medicine, thereby make preferably whether patient and paramedic have followed appropriate processes through the further affirmation of the identification of system, and make system log (SYSLOG) make the personnel of medicament; Thereby follow the tracks of; For example, if anyone unsuitable medicine that used, in final audit trail with fairly obvious.After the step 1925, if all users are not recognized that all step 1920 is got back in the control path, through any other user of system identification.
In case all users through identification, control path to step 1927, the medicine that prescribed regimen according to the rules will be taken this moment is recognized.Therefore, the user is pointed out through device 1600 and is used image static or video, text identification image; Or the method for other identification medicine is gathered medicine bottle or other containers; Pill, or the medicine of other formulations can also be confirmed suitable quantity; Dosage, and any potential essential or dangerous drug regimen.As stated, if video is confirmed can not carry out for a certain reason, the user can be provided indications audio frequency or other drug and other information that need by system prompt.Then, this image, the affirmation information of video program or other receptions will with the prescription relevant image compare.If it is wrong that the analysis medicine of process analysis module 1635 is determined, device 1600 will provide medicine incorrect warning to the user.The user can be selected another medicine is carried out to picture then by prompting.
Alternatively, the present invention estimates that the user can show device 1600 with multiple medicine, and making device that which kind of provide is the suggestion of correct medicine.Therefore, the user can use this video imaging apparatus scanning medical cupboard, and making system that which kind of indicate is correct medicine.Quite important when the order of the medicine of ingesting, perhaps take similar medicine and when distinguishing each other medicine and having difficulties, it is valuable that this point is proved to be as two people.In case correct medicine is identified, control path to step 1930.
In step 1930, device 1600 provides user prompt and other instructions to patient, current paramedic, about the instruction of how to take medicine according to the above-mentioned prescription guide of confirming in the clinical testing under consideration.This instruction makes the user can receive further information or instruction through seek extra help to system in case of necessity.Particularly requiring under the situation of detailed planninng, can estimate that the user possibly obtain the sample and the instruction of video.In addition, according to the present invention, for the process of taking of complicacy; Possibly adopt traditional video conference, VOIP meeting, traditional teleconference; Perhaps any other suitable communication system and expert carry out the two-way video meeting; Make paramedic or patient can receive about the live telecast of taking instruction, all through device 1600, possibly bring the permission of additional characteristic and element these add functional.Thereby these instructions and prompting can provide success or the failure of confirming the specific instruction group by clinical trial management person.Therefore; DO need not tested in clinical testing, thereby the instruction group also need test to confirm which kind of is best for everyone, or for demography group or the like; Or for final user when medicine is provided to the public, thereby realize the public's better compliance.Along with the growth of clinical testing quantity, the place of these tests becomes and internationalizes more, will become more important through a plurality of clinical trial management persons of system management according to the present invention.
When following these command prompts, storer 1620 gathered and be stored into to the actual act of taking preferably in step 1935 through collecting device 1610 by device 1600 with video program.Therefore this takes one or more discernible gestures that preferably include instruction suggestion as described above.Therefore, patient or keeper possibly be provided the one or more imaging applications for application or instructions of taking, thereby ensuing these programs are used for confirming the compliance to specific prescribed regimen.In addition, the long-time or keeper that can be confirmed as feasible test participant that pauses further understands the zone of bringing problem in depth.The video program of this collection can use in many ways according to the present invention.At first, take the action of medicine through processor 1630 and 1635 pairs of analysis modules and carry out real-time inspection, and compare with video program desirable or expectation.If confirm that medicine is taken with the mode of mistake, perhaps take with the mode that patient is harmful to, will cut out immediately through installing 1600 give a warning immediately suggestion paramedic or patients in step 1940.In addition, under some extreme case, can notify doctor or other paramedives, perhaps under extremely dangerous situation, ambulance or other responding agencies possibly be scheduled for this place nursing timely is provided.
Notice also possibly be provided for clinical trial management person, warns its one or more patients that there is the compliance problem in these rules.If this problem is proved to be independently, optional instruction or individual help all can remedy this state, thereby make patient to test significant data are provided.If generally lack compliance, clinical trial management person possibly change instruction for all participants, perhaps even ask all participants to return to accept further on-the-spot instruction.Under any one situation,, cause the research failure to be avoided owing to lack the rules compliance, so the expense of clinical testing reduce greatly because the participant all can keep under study for action.Do not comprise the image of identity characteristic etc. through employing, can be provided for the keeper, make this report accurately show privacy and the secret of having protected patient when medicine is how to take based on this report that generally lacks compliance.If can not obtain videograph, also can adopt aforesaid other confirmation methods, as the videograph program, confirm automatically.
If do not require urgent nursing or warning, control path to step 1945 at this moment, is more formally gathered video image, and is sent to teledata and calculating storaging unit 1800 and is used for analyzing various other not dangerous situations.Image can carry out the part to be gathered and stores, and in batch processed, serves as central server, and perhaps image also can be gathered and send to remote service storage unit 1800 and be used for analyzing timely and storing.This analysis can consider to propose to improve to the paramedic accuracy of dosage, reduces medication pain, or the like suggestion.In addition, participate in patients current or a plurality of clinical testings and/or paramedic in a large number and all can obtain this video, thereby the validity of various series of instructions is tested and checked, if meet with identical problem then change always.If such research does not have the present invention almost can not carry out, because in the clinical protocol of any kind, what individuality can be careful when taking medicine is many, therefore can not make mistakes.When they returned in to the home or get back in the life clocklike, Here it is proposed the opportunity of compliance kimonos with matters.According to the present invention, can analyze reaction to instruction, also can remedy owing to obscuring or be difficult to follow the compliance deficiency that instruction causes, better or more available instruction is provided, thus the compliance of improvement project.Do not have the present invention, clinical trial management person possibly just not know these matters.Because in a single day existence of the present invention, these matters occur and can be notified, thereby guarantee the integrality of clinical testing.
In any case, analyze through these, can point out it possibly is problematic instruction area in step 1950 generation warning for any warning or the suggestion of instruction.These video programs are if needing also can store in step 1955 is used for long-term analysis, and terminal processes.In addition, maintain in the clinical testing in order to encourage patient, the notice that lacks compliance can be used to change the remuneration that patient receives in clinical testing.Therefore, make patient obtain higher remuneration, in scheme bigger power is provided for the patient compliance to the compliance of scheme.
Participating in this clinical testing or other medical science takes the patient's of program trend and can obtain monitoring according to additional diagnosis annex through installing 1600; For example patient's blood pressure or other measurable numerical value; And the relation between these measured quantities and the drug administration also can be observed; Make patient can obtain the pharmaceutical admixtures of customization of individual character potentially, can make amendment to the dosage or the frequency of taking based on individual reaction to specific prescribed regimen.In addition, characteristic of the present invention as stated makes user's the movable record of interaction and user, thereby and bad reaction or the like all can be dissolved into and provide further information confirming optional instruction group in the system, the modification of medicine, or the like.
Therefore, this device 1600 has increased validity and has allowed this clinical testing has better been controlled.Following the difficulty of rules can almost confirm in real time.The change of medicine rules can easily realize and pass on to patient and their prescription doctor.New training module, thus comprising that video, text or other instructions can provide in test improves compliance.Inventory management is more easy, and guarantees that all patients have the suitable consumption of medicine and other goods and materials.This system also can be by a medical science supplier, doctor's group or network, insurance company, government organs, nursing home, poorhouse, family health care supplier or the like with device 100; Perhaps other groups are used, thereby follow the tracks of a large amount of patients and relevant residential care personnel, doctor or other drug keeper.
According to the present invention; All communications are all to have carried out in this locality or the long-range a plurality of storage unit encrypting or other protections transmitting or being stored in, to meet the desired any regulation of security matters and storage and maintenance medical science and patient medical healthcare information.
Optional embodiment of the present invention provides one or more following supplementary features.Device 1600 is not the simple video acquisition that a traditional approach is provided, but can be provided a night vision, ultrared, or other required acquisition plan.Device 1600 estimates to be provided the numerous devices management characteristic; Comprise that selection is with ability colored and that black and white video stores and transmits; To patient or similar personnel's automatic focusing, and comprise when they walk out the room and follow the trail of, if desired; Any identity information is deleted from the video that transmits, thereby kept anonymous.Device 1600 possibly comprise and indicates the structure that need recharge, and comprise the sleep pattern of extending battery life.Estimate that further this device 1600 can be used as patient's watch-dog, this device comprises for the suggestion of falling, screaming or the like with the sound that standby mode can " be heard " or " seeing " patient sends.Also can provide automatic reaction with state through whole loudspeaker or the like visit patient.The transfer system of this device 100 is notified the suitable relevant personnel then.Therefore, portability and a plurality of usable range provide additional beneficial effect for the use of this device.
Therefore, according to the present invention, the method and apparatus that provides has been realized the automatic affirmation of medicine to the compliance of taking rules, and a kind of exact method that is used to confirm and study the prescription drug instructions of taking is provided.
Thereby can find out; According in preceding description; The top scheme of mentioning all is clearly and can realizes efficiently; Do not breaking away under the condition of essence of the present invention and scope, it all is possible making any variation when stating method and structure in realization, all is as an example and unrestricted in all the elements shown in above-mentioned instructions and the accompanying drawing.
It is also understood that this instructions has covered the present invention's all general and special characteristics described herein, and all statements as a kind of language of the scope of the invention all fall into scope of the present invention.

Claims (20)

1. a confirmation method of taking medicine comprises the steps:
Reception information, this information Recognition certain drugs prescribed regimen;
Confirm to take one or more processes of this prescribed regimen;
Discern one or more operation programs relevant with this process;
Gather the actual operation program of taking this prescribed regimen;
Thereby the operation program that will be gathered and recognized action program compare the difference of confirming therebetween; And
If confirm distinct then give notice.
2. the method for claim 1 is characterized in that, said prescribed regimen is provided by the medical expert.
3. the method for claim 1 is characterized in that, said prescribed regimen obtains from the medical science database retrieval.
4. the method for claim 1 is characterized in that, the said process that is used to take prescribed regimen obtains from database retrieval.
5. method as claimed in claim 5 is characterized in that, the said process that retrieves that is used to take prescribed regimen is revised by the medical expert.
6. the method for claim 1 is characterized in that, further comprises the steps:
Thereby retrieval patient's medical history taking information receives the medicine of taking; And
Confirm that the medicine of taking is safe to patient.
7. the method for claim 1 is characterized in that, further comprises the steps:
Take before one or more operation programs of this prescribed regimen the characteristic of the specific medication of confirming to be used to take like this in collection; And
In case confirming said definite characteristic is not promptly to give a warning with the relevant medicine of prescribed regimen that is about to form.
8. method as claimed in claim 7 is characterized in that, said warning comprises with the medical expert and directly contacting.
9. the method for claim 1 is characterized in that, further comprises the steps:
Gather the actual operation program of taking this prescribed regimen in the instance a plurality of taking;
Thereby the operation program that will be gathered and the video program of identification compare the difference of confirming therebetween; And
Take the compliance analysis that instance provides specific prescribed regimen according to a plurality of.
10. method as claimed in claim 9 is characterized in that further comprising the steps: provides extra-instruction according to the analysis that is provided to medication management person.
11. the method for claim 1 is characterized in that, said notice comprises with the medical expert and directly contacting.
12. the method for claim 1 is characterized in that, said notice comprises the extra-instruction that provides to medication management person.
13. a confirmation method of taking medicine comprises the steps:
Authentication prescription medical expert;
Receive information this information Recognition certain drugs prescribed regimen from the medical expert of authentication;
From one or more databases, confirm to take one or more processes of this prescribed regimen, this process comprises the prescribed regimen information of the prescription information that provides according to the medical expert by authentication;
If need, revise this process by the medical expert of authentication;
According to the prescribed regimen of being taken a series of instruction is provided;
One or more operation programs that identification is relevant with this instruction;
Gather the actual operation program of taking this prescribed regimen in the prescribed regimen a plurality of taking;
Thereby the operation program that will be gathered and recognized action program compare the difference of confirming therebetween;
If in comparison step, confirm distinct then emergency notice is provided, this difference may make the patient who is accepting prescribed regimen face a danger; And
If in comparison step, confirm distinct then notice is provided, this difference may improve further taking of this prescribed regimen.
14. method as claimed in claim 13 is characterized in that, further comprises the steps: statistical study is carried out in the difference of in comparison step, confirming.
15. method as claimed in claim 13 is characterized in that, the difference of in comparison step, confirming comprises confirms wrong medicine.
16. method as claimed in claim 13 is characterized in that, the difference of in comparison step, confirming comprises confirms wrong drug dose.
17. method as claimed in claim 13 is characterized in that, the difference of in comparison step, confirming comprises confirms the wrong process of taking.
18. an affirmation system of taking medicine comprises:
Authenticate device is used for authentication prescription medical expert;
Input equipment is used for receiving information from the medical expert of authentication, this information Recognition certain drugs prescribed regimen;
Database comprises the information of taking of writing out a prescription,
Storage facilities, be used for storing select from database and take and according to a series of instructions of the prescribed regimen of being taken and one or more operation programs relevant with these instructions with the prescription that is associated of drug prescription of identification;
Collecting device is used for gathering the actual operation program of taking this prescribed regimen at a plurality of prescribed regimens of taking;
Processor, thus be used for operation program of being gathered and recognized action program are compared the difference of confirming therebetween; And
Output unit, if be used for confirming the distinct emergency notice that promptly provides in comparison step, this difference may make the patient who is accepting prescribed regimen face a danger; And if be used for confirming the distinct notice that promptly provides that this difference may improve further taking of prescribed regimen in comparison step.
19. system as claimed in claim 18 is characterized in that, the information that is stored in the storage facilities can be revised by the medical expert of authentication.
20. system as claimed in claim 18 is characterized in that, allows its identification thereby said collecting device further is adapted to gather the image of specific medication.
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US12/620,686 US20110119073A1 (en) 2009-11-18 2009-11-18 Method and Apparatus for Verification of Medication Administration Adherence
US12/646,383 US20110153360A1 (en) 2009-12-23 2009-12-23 Method and Apparatus for Verification of Clinical Trial Adherence
US12/646,603 US8666781B2 (en) 2009-12-23 2009-12-23 Method and apparatus for management of clinical trials
US12/646,603 2009-12-23
US12/646,383 2009-12-23
US12/728,721 US9183601B2 (en) 2010-03-22 2010-03-22 Method and apparatus for collection of protocol adherence data
US12/728,721 2010-03-22
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105120827A (en) * 2013-03-14 2015-12-02 艾治疗技术公司 Apparatus and method for recognition of suspicious activties
CN105395369A (en) * 2015-11-27 2016-03-16 广东欧珀移动通信有限公司 Drug use reminding method, terminal, medicine box device and system
CN109360621A (en) * 2018-09-13 2019-02-19 苏州医号线医药科技有限公司 Prescription drug compliance management method and management system based on NLP
US10646101B2 (en) 2010-05-06 2020-05-12 Aic Innovations Group, Inc. Apparatus and method for recognition of inhaler actuation
US10650697B2 (en) 2010-05-06 2020-05-12 Aic Innovations Group, Inc. Apparatus and method for recognition of patient activities
US10872695B2 (en) 2010-05-06 2020-12-22 Ai Cure Technologies Llc Apparatus and method for recognition of patient activities when obtaining protocol adherence data
US11170484B2 (en) 2017-09-19 2021-11-09 Aic Innovations Group, Inc. Recognition of suspicious activities in medication administration

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10116903B2 (en) 2010-05-06 2018-10-30 Aic Innovations Group, Inc. Apparatus and method for recognition of suspicious activities
EP2743849A1 (en) * 2012-12-10 2014-06-18 WEPA Apothekenbedarf GmbH & Co.KG System for improving patients' compliance with treatment
JP2016531334A (en) * 2013-06-06 2016-10-06 ヤンセン ファーマシューティカ エヌ．ベー． Electrical medication adherence, identification, and distribution
US10108975B1 (en) 2013-06-30 2018-10-23 RxANTE, INC. Medical accountable provider platform
US10991458B2 (en) * 2014-07-22 2021-04-27 Amgen Inc. System and method for detecting activation of a medical delivery device
US20160314276A1 (en) * 2015-04-24 2016-10-27 Hand Held Products, Inc. Medication management system
BE1022898B1 (en) * 2015-06-03 2016-10-10 Oystershell Nv METHOD FOR SELF-CARE AID ASSISTANCE AND THEREFORE SUITABLE MEANS
WO2016210267A1 (en) * 2015-06-26 2016-12-29 Resolution Information, Llc Computerized system and methods for biometric-based timekeeping
US11842804B2 (en) * 2018-12-27 2023-12-12 John Woodyear System and method for the verification of medication
US11923058B2 (en) * 2018-04-10 2024-03-05 Electronic Caregiver, Inc. Mobile system for the assessment of consumer medication compliance and provision of mobile caregiving
US20210327187A1 (en) * 2020-04-17 2021-10-21 Alclear, Llc Medical screening entry

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5752621A (en) * 1995-03-20 1998-05-19 Eigen Technology Inc. Smart automatic medication dispenser
US20020026330A1 (en) * 2000-08-23 2002-02-28 Klein Edward E. System and method for patient medication management and compliance using a portable computing device
US20020143563A1 (en) * 2001-04-02 2002-10-03 Hufford Michael R. System for clinical trial subject compliance
CN101553841A (en) * 2006-12-06 2009-10-07 微软公司 Patient monitoring via image capture

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7359214B2 (en) 2004-09-28 2008-04-15 Amphenol Corporation Backplane with routing to reduce layer count
US8538775B2 (en) * 2007-08-16 2013-09-17 Qualcomm Incorporated Mobile wireless medication management system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5752621A (en) * 1995-03-20 1998-05-19 Eigen Technology Inc. Smart automatic medication dispenser
US20020026330A1 (en) * 2000-08-23 2002-02-28 Klein Edward E. System and method for patient medication management and compliance using a portable computing device
US20020143563A1 (en) * 2001-04-02 2002-10-03 Hufford Michael R. System for clinical trial subject compliance
CN101553841A (en) * 2006-12-06 2009-10-07 微软公司 Patient monitoring via image capture

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11328818B2 (en) 2010-05-06 2022-05-10 Ai Cure Technologies Llc Apparatus and method for recognition of patient activities when obtaining protocol adherence data
US11862033B2 (en) 2010-05-06 2024-01-02 Aic Innovations Group, Inc. Apparatus and method for recognition of patient activities
US11682488B2 (en) 2010-05-06 2023-06-20 Ai Cure Technologies Llc Apparatus and method for recognition of patient activities when obtaining protocol adherence data
US10646101B2 (en) 2010-05-06 2020-05-12 Aic Innovations Group, Inc. Apparatus and method for recognition of inhaler actuation
US10650697B2 (en) 2010-05-06 2020-05-12 Aic Innovations Group, Inc. Apparatus and method for recognition of patient activities
US10872695B2 (en) 2010-05-06 2020-12-22 Ai Cure Technologies Llc Apparatus and method for recognition of patient activities when obtaining protocol adherence data
US11094408B2 (en) 2010-05-06 2021-08-17 Aic Innovations Group, Inc. Apparatus and method for recognition of inhaler actuation
CN105120827A (en) * 2013-03-14 2015-12-02 艾治疗技术公司 Apparatus and method for recognition of suspicious activties
CN105120827B (en) * 2013-03-14 2019-10-15 艾治疗技术公司 The device and method distinguished for suspicious activity
CN105395369B (en) * 2015-11-27 2019-02-26 Oppo广东移动通信有限公司 A kind of medication based reminding method, terminal, medicine box device and system
CN105395369A (en) * 2015-11-27 2016-03-16 广东欧珀移动通信有限公司 Drug use reminding method, terminal, medicine box device and system
US11170484B2 (en) 2017-09-19 2021-11-09 Aic Innovations Group, Inc. Recognition of suspicious activities in medication administration
CN109360621A (en) * 2018-09-13 2019-02-19 苏州医号线医药科技有限公司 Prescription drug compliance management method and management system based on NLP

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